A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
Phase: NA
Conditions: Biliary Stricture
Sponsor: Boston Scientific Corporation

WallFlex Biliary FC Chronic Pancreatitis RCT   
90913882 Rev/Ver AC  
NCT01543256 Protocol 
February 15, 2013 
E7058 
 
 
 
A Multi-Center, Prospective, Randomized Study Comparing 
Removable, Self-Expanding Metal Stents to Plastic Stents 
for the Treatment of Benign Biliary Strictures Secondary to Chronic 
Pancreatitis 
 
WallFlex Biliary FC Chronic Pancreatitis RCT 
NCT01543256 
Clinical Protocol 
February 15, 2013 
 
 
 
 
 
 
 
 
 
 
 
 
 THESE DOCUMENTS ARE THE PROPERTY OF BOSTON SCIENTIFIC CORP. AND SHALL NOT BE REPRODUCED, DISTRIBUTED, DISCLOSED OR USED FOR 
MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN CONSENT OF BOSTON SCIENTIFIC CORP. 

 
 
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February 15, 2013 
 
Boston Scientific 
FINAL 
 WallFlex Biliary FC Chronic Pancreatitis RCT Protocol 
 
 
90913882 Rev/Ver AC 
 
 
Page 1 of 36 
 
A Multi-Center, Prospective, Randomized Study Comparing  
Removable, Self-Expanding Metal Stents to Plastic Stents  
for the Treatment of Benign Biliary Strictures Secondary to Chronic 
Pancreatitis  
 
WallFlex Biliary FC Chronic Pancreatitis RCT 
 
 
CLINICAL PROTOCOL 
90913882 / E7058 
 
 
Sponsored By 
Boston Scientific Corporation 
100 Boston Scientific Way 
Marlborough, MA 01752-1234 
USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 

 
 
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Page 2 of 36 
 
 
 
Contact Information 
Role 
Contact  
Clinical Contact 
Erin Leckrone 
Clinical Project Manager 
Boston Scientific Corporation 
100 Boston Scientific Way 
Marlborough, MA 01752-1234 
USA 
Coordinating Principal 
Investigator 
D. Nageshwar Reddy, MD, DM, FAMS, FRCP 
Chairman 
Asian Institute of Gastroenterology  
6-3-661, Somajiguda  
Hyderabad - 500 082  
India 
 
Original Release: January 1, 2012 
Current Version: February 15, 2013

 
 
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Investigator’s Signature Page 
 
Study Title 
A Multi-Center, Prospective, Randomized Study Comparing  
Removable, Self-Expanding Metal Stents to Plastic Stents  
for the Treatment of Benign Biliary Strictures Secondary to 
Chronic Pancreatitis  
 
Protocol Version 
90913882 Rev/Ver AA  
 
Study Center 
 
_____________________________________________ 
(Print name of study center) 
 
I, the undersigned, have read and understand the protocol specified above and agree on its 
content. I agree to perform and conduct the trial as described in the protocol and in 
accordance with applicable laws and regulations. In addition, when applicable, I agree to 
enlist sub-investigators who also agree to perform and conduct the trial as described in the 
protocol.  
 
 
 
 
 
Principal Investigator (Print Name) 
 
 
 
 
 
 
Principal Investigator (Signature) 
 
 
 
 
 
Date 
 
 
 

 
 
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Protocol Synopsis 
 
Full Title 
A Multi-Center, Prospective, Randomized Study Comparing  
Removable, Self-Expanding Metal Stents to Plastic Stents  
for the Treatment of Benign Biliary Strictures Secondary to Chronic 
Pancreatitis  
Short Title 
WallFlex Biliary FC Chronic Pancreatitis RCT 
Primary Objective To compare the use of Self Expanding Metal Stents (SEMS) to plastic 
stents for the treatment of benign biliary strictures secondary to chronic 
pancreatitis as it pertains to stricture resolution rates, complication rates and 
number of ERCP procedures during 24 months. 
Study Devices 
Group A: Metal Stents – MS Arm 
WallFlex™ Biliary RX Fully Covered Stent System RMV 
 
Group B. Plastic Stents – PS Arm 
Per Investigator preference 
Study Design 
Prospective, multi-center, randomized 
Planned Number 
of Subjects 
164 
Planned Number 
of Sites 
Up to 15 
Primary Endpoint Stricture resolution at 24 months 
Secondary 
Endpoints 
1. Occurrence of adverse events related to the stent and/or the stent 
placement or removal procedures  
2. Number of ERCP procedures through 24 months after initial stent 
placement 
3. Ability to deploy the stent(s) in satisfactory position  
4. Stent Removal: 
 Ability to remove the stent(s) without serious stent removal 
related adverse events at each procedure involving removal 
of stent(s) (technical success at removal) or 
 Complete distal migration without serious stent removal 
related adverse events 
5. Liver Function Tests (LFT’s): 
 Baseline LFTs compared to LFTs taken at time of original 
plastic stent placement for any subject with a prior plastic 
stent 

 
 
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 LFT improvement at 1 month post-study treatment 
compared to baseline LFTs (and/or compared to LFTs taken 
at time of original plastic stent placement for any subject 
with a prior plastic stent) 
 LFTs at month 24 compared to LFTs at removal of last stent 
(applicable for subjects who had not been re-stented at time 
of month 24 visit) 
6. Health Economic Endpoints: 
 Number of outpatient procedures 
 Number of hospitalizations 
 Duration of hospitalizations 
 Length of procedures 
 Number of devices 
Randomization 
Subjects will be randomized at the time of the procedure to a 1:1 ratio 
between Metal Stent Arm (Group A – MS) and Plastic Stent Arm (Group B 
– PS). 
Follow-Up 
Schedule 
 Baseline: Subject screening, enrollment, LFTs and symptoms. 
 Study Treatment Procedure: 
o Group A (MS): Stent Placement 
o Group B (PS): Stent Placement: Two or more 8.5 Fr. or 10 Fr. 
PS whenever possible 
 1 Month Follow-up: 
o Group A (MS): LFTs and symptoms 
o Group B (PS): LFTs and symptoms  
 Stent Exchange Follow-up: 
o Group A (MS): None 
o Group B (PS): Month 4 and Month 8   
 Stent Removal: 
o Group A (MS): Removal at Month 12, LFTs and symptoms 
o Group B (PS): Removal of last stents at Month 12, LFTs and 
symptoms 
 Post-Stent Removal Follow-Up 
o Group A (MS): Month 24 – LFTs and symptoms 
o Group B (PS): Month 24 – LFTs and symptoms 
 Additional ERCP visits as needed 
 
Note: Recurrent strictures will be treated with a metal stent in Group A 
(MS) and with plastic stents in Group B (PS) – no cross-over. Re-
stenting after the per-protocol 12 month stenting period will be 
considered primary endpoint failures. Follow-up, however, will 
continue until Month 24 after initial stent placement for all subjects, in 
order to assess all secondary endpoints in a comparative fashion for the 

 
 
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Page 6 of 36 
MS and PS arms. 
Key Inclusion 
Criteria 
 
Age 18 or older 
 
Willing and able to comply with the study procedures and provide 
written informed consent to participate in the study 
 
Chronic pancreatitis 
 
Symptomatic bile duct stricture (defined by cholangitis or persistent 
jaundice for at least one month or cholestasis associated with at least 3 
times normal alkaline phosphatase levels) documented at time of 
enrollment for naïve stricture or at the time of prior plastic stent 
placement in strictures that had one prior plastic stent inserted.12 
 
Common bile duct stricture based on imaging assessment of dilatation 
of the common and/or intrahepatic bile ducts 
Key Exclusion 
Criteria 
 
Biliary stricture of benign etiology other than chronic pancreatitis  
 
Prior biliary metal stent or any plastic stenting other than one plastic 
stent of 10 Fr or less for 6 months or fewer  
 
Developing obstructive biliary symptoms associated with an attack of 
acute pancreatitis  
 
Biliary stricture of malignant etiology 
 
Stricture within 2 cm of common bile duct bifurcation 
 
Known bile duct fistula or leak 
 
Subjects for whom endoscopic techniques are contraindicated 
 
Known sensitivity to any components of the stent or delivery system 
 
Symptomatic duodenal stenosis (with gastric stasis) 
 
Participation in another investigational study within 90 days prior to 
consent  
 
Investigator Discretion 
Statistical 
Hypothesis 
A literature search of metal and plastic stenting for treatment of benign 
biliary strictures secondary to chronic pancreatitis yielded 4 articles 
representing 70 subjects treated with metal stenting (MS) 1,9-11 and 3 articles 
representing 60 subjects treated with plastic stenting (PS) 3,4,8. 
The following meta-analysis was conducted of the probability of stricture 
resolution:  
 Metal Stenting: A meta-analysis of the stricture resolution rate during 
the reported follow-up after initial stent placement yields a proportion 

 
 
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90913882 Rev/Ver AC 
 
 
Page 7 of 36 
of 0.762 [95% CI: 0.593 – 0.895] 1,9-11. 
 Plastic Stenting: A meta-analysis of the stricture resolution rate during 
the reported follow-up after initial stent placement yields a proportion 
of 0.611 [95% CI: 0.311 – 0.870] 3,4,8. 
Statistical testing will be performed to determine if the rate of stricture 
resolution for the metal stent is non-inferior to the plastic stent group. The 
null hypothesis is that the stricture resolution rate is non-inferior in the Metal 
Stent Arm versus the Plastic Stent Arm: 
 
ܪ݋: ߨ௧௘௦௧െߨ௖௢௡௧௥௢௟ ൒∆  (Inferior) 
 
ܪܽ: ߨ௧௘௦௧െߨ௖௢௡௧௥௢௟ ൏∆  (Non-inferior) 
where ߨ௧௘௦௧ 
 and ߨ௖௢௡௧௥௢௟ are the probabilities of having a stricture resolution in 
the metal stent arm and the plastic stent arm respectively, and ∆ is defined as 
the non-inferiority margin. 
 
The sample size was calculated for a one-sided 0.050 Farrington-Manning 
test using SAS 9.2®. If the P value from the Farrington-Manning test is 
<0.05 then the metal stent group will be considered non-inferior to the 
plastic stent group. The expected probability of stricture resolution in the 
metal stent arm and plastic stent arm is 66.0%, which was taken from the 
95% CIs from the meta-analysis above. The non-inferiority margin (∆) is 
20%.  Given these assumptions and a one-sided 5% significance level, 2 x 
74 = 148 subjects will provide 80% power to reject the null hypothesis, that 
the metal stent group is inferior to the plastic stent group. To compensate 
for possible loss of subjects after enrollment and complete assessment of 
inclusion/exclusion criteria, an additional 10% of subjects will be enrolled, 
for a total of 2 x 82 = 164.  
 
 
 

 
 
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Table of Contents 
1. 
Introduction ..................................................................................................................... 10 
1.1.  Introduction .............................................................................................................. 10 
1.2.  Plastic Stents in Chronic Pancreatitis Strictures ...................................................... 10 
1.3.  Metal Stents in Chronic Pancreatitis Strictures ........................................................ 11 
2. 
Device Description ........................................................................................................... 11 
3. 
Primary Objectives .......................................................................................................... 12 
4. 
Endpoints .......................................................................................................................... 12 
4.1.  Primary Endpoint ..................................................................................................... 12 
4.2.  Secondary Endpoints ................................................................................................ 13 
5. 
Design ................................................................................................................................ 14 
5.1.  Inclusion Criteria:..................................................................................................... 14 
5.2.  Exclusion Criteria: ................................................................................................... 14 
6. 
Subject Accountability .................................................................................................... 15 
6.1.  Point of Enrollment .................................................................................................. 15 
6.2.  Withdrawal ............................................................................................................... 15 
7. 
Study Methods ................................................................................................................. 15 
7.1.  Data Collection ........................................................................................................ 15 
7.2.  Study Candidate Screening ...................................................................................... 17 
7.3.  Informed Consent ..................................................................................................... 17 
7.4.  Study Visits .............................................................................................................. 17 
7.5.  Study Completion .................................................................................................... 19 
7.6.  Source Documents ................................................................................................... 19 
8. 
Statistical Considerations ............................................................................................... 19 
8.1.  Objective .................................................................................................................. 19 
8.2.  Justification for Study Design and Sample Size Calculations ................................. 20 
8.3.  Eligibility of Subjects, Exclusions, and Missing Data ............................................. 20 
8.4.  Analysis Populations ................................................................................................ 20 
8.5.  Analysis .................................................................................................................... 21 
8.6.  Statistical Analysis ................................................................................................... 21 
9. 
Data Management ........................................................................................................... 22 
9.1.  Data Collection, Processing, and Review ................................................................ 22 
9.2.  Data Retention .......................................................................................................... 22 
10.  Potential Risks and Benefits ........................................................................................... 22 
10.1.  Anticipated Adverse Device Effects ........................................................................ 22 
10.2.  Risk Minimization Actions ...................................................................................... 24 
10.3.  Anticipated Benefits ................................................................................................. 24 
10.4.  Risk to Benefit Rationale ......................................................................................... 24 
11.  Safety Reporting .............................................................................................................. 24 
11.1.  Definitions and Classification .................................................................................. 24 
11.2.  Relationship to Study Device(s) .............................................................................. 26 
11.3.  Investigator Reporting Requirements ...................................................................... 27 

 
 
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11.4.  Boston Scientific Device Deficiencies ..................................................................... 27 
11.5.  Reporting to Regulatory Authorities / IRBs / ECs / Investigators ........................... 27 
12.  Amendments .................................................................................................................... 27 
13.  Deviations ......................................................................................................................... 28 
14.  Device/Equipment Accountability ................................................................................. 28 
15.  Compliance ....................................................................................................................... 28 
15.1.  Statement of Compliance ......................................................................................... 28 
15.2.  Investigator Responsibilities .................................................................................... 28 
15.3.  Institutional Review Board/ Ethics Committee........................................................ 30 
15.4.  Sponsor Responsibilities .......................................................................................... 31 
15.5.  Insurance .................................................................................................................. 31 
16.  Monitoring ........................................................................................................................ 31 
17.  Informed Consent ............................................................................................................ 32 
18.  Suspension or Termination ............................................................................................. 33 
23.1  Premature Termination of the Study ........................................................................ 33 
23.2  Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval ................................................................................................................... 33 
23.3  Requirements for Documentation and Subject Follow-up ....................................... 33 
23.4  Criteria for Suspending/Terminating a Study Center .............................................. 34 
19.  Publication Policy ............................................................................................................ 34 
20.  Bibliography ..................................................................................................................... 35 
21.  Abbreviations and Definitions ........................................................................................ 36 
 
Table of Tables 
Table 1.  Study Event Schedule .............................................................................................. 16 
Table 11.1-1: Adverse Event Definitions ............................................................................... 24 
Table 11.2-1: Criteria for Assessing Relationship of Study Device to Adverse Event .......... 26 
 

 
 
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1. Introduction 
1.1. 
Introduction 
Benign strictures of the common bile duct may occur in approximately 3%-45% of subject 
with chronic pancreatitis.1-5 Previously, surgery was typically performed for subjects with 
chronic pancreatitis, but is associated with high morbidity and mortality.3-5 Chronic 
pancreatitis subjects are also typically poor surgical candidates due to concomitant 
malnutrition, cirrhosis or portal hypertension.1,3,4  Non-surgical candidates will usually 
undergo endoscopic treatment with one or more multiple plastic stents placed, resulting in 
adequate short-term resolution of pancreatitis but associated with high occlusion and 
migration rates and poor long-term results.1,3 
Plastic stents, which are intended for temporary placement and are removable, have become 
standard of care for endoscopic treatment of benign strictures due to chronic pancreatitis.2-8 
More recently, physicians are using self-expandable metal stents (SEMS) for treatment of 
and removal from such strictures due to the long-term patency, lower occlusion and 
obstruction rates, of metal stents compared to single or multiple plastic stents. 1,9-11   
 
A summary of literature review below examines plastic stent placement and instances of 
metal stent placement for treatment of benign strictures in subjects with chronic pancreatitis. 
1.2. 
Plastic Stents in Chronic Pancreatitis Strictures 
A total of six studies (253 subjects) were analyzed for use of single or multiple plastic stents 
for benign biliary strictures; there were a total of 226 subjects with strictures due to chronic 
pancreatitis included in these studies.2-6,8  The average number of ERCP’s (Endoscopic 
Retrograde Cholangiopancreatography) with stent exchanges per subject was 4.3 (range 1-
17).3,5,8 Subjects with single plastic stents placed typically underwent stent exchange at 3-6 
month intervals resulting in 1-4 exchanges per subject.3,5,6  These subjects also had a stent 
indwell time ranging from 10-15 months.3,4,6  Subjects with multiple plastic stents placed had 
stent indwell times ranging from 12-34 months.3,8 
 
Overall clinical success ranged from 24%-46% for subjects treated with a single plastic 
stent2-5, and 62%-92% for subjects treated with multiple plastic stents.3,8  In the subset of data 
available for chronic pancreatitis subjects treated with single plastic stents, success rates 
ranged from 7.7%-46%3-6 and one study specifying use of multiple plastic stents for chronic 
pancreatitis subjects had a reported success rate of 44%.8 
 
Complications inclusive of all subjects in all studies of plastic stents included migration 
(10.2%-13%)3,4, cholangitis (6.8%)8, bleeding (5.1%)4, occlusion (7.6%-46.5%)4,5, 
pancreatitis (1.7%-3.4%)5,8, liver abscess (1.7%)5, dislocation (1.7%)5, and clogging 
(92.3%).6 

 
 
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1.3. 
Metal Stents in Chronic Pancreatitis Strictures 
A total of four studies (186 subjects) were analyzed for use of partially covered (n=99 
subjects) or fully covered metal stents (n=87 subjects) for benign biliary strictures; there 
were a total of 71 subjects with strictures due to chronic pancreatitis included in these 
studies.1,9-11  Types of stents used included the partially covered Wallstent (Boston 
Scientific), uncovered Wallstent (Boston Scientific), Viabil, fully covered metal stent with an 
anchoring flap (M.I. Tech) and a fully covered metal stent with both ends flared (Standard 
Sci Tech).  Behm et al1 noted a range of 1-3 procedures per subject.  Stent indwell times 
ranged from 6 months to 28 months.1,9,11  Success of metal stents in just chronic pancreatitis 
subjects ranged up to 95%.1 
 
Complications inclusive of all subjects in all studies of metal stents included migration (5%-
16.2%)1,9,11, bleeding (1%-5%)1,9,10, pain (2%-5%)1,9,10, pancreatitis (5%-13.9%)1,9,11, 
cholangitis (4.6%-35%)11 and  occlusion (9.3%)11. 
2. Device Description 
The WallFlex Biliary RX Fully Covered Stent System RMV is indicated for use in the 
palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment 
of benign biliary strictures, per CE Mark. This clinical study will be conducted only in 
countries where this indication for use is cleared or approved per local regulatory 
requirements. Enrolled subjects will have benign biliary strictures secondary to chronic 
pancreatitis. 
 
Study devices are labeled on the box and inner pouch and include information not limited to 
name of legal manufacturer, device name and dimensions, lot number, expiration date and 
investigational use statement. Device labeling will be provided in local language(s) as per 
national regulations. 
 
For a detailed description of the WallFlex Biliary RX Fully Covered Stent System RMV, 
please reference the Directions for Use (DFU) included in each device package.  
The DFU indicates stent placement for the following use: the palliative treatment of biliary 
strictures produced by malignant neoplasms, and for treatment of benign biliary strictures. 
Investigators should use the WallFlex Biliary RX Fully Covered Stent System RMV in 
accordance with the DFU. 
 
 

 
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Confidentia
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Page 12
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Confidentia
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ns eligible f
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t the 
ent 
e 
e 
dge 
se 
at 
LFTs 
nt for 
for 

 
 
Confidential 
February 15, 2013 
 
Boston Scientific 
FINAL 
 WallFlex Biliary FC Chronic Pancreatitis RCT Protocol 
 
 
90913882 Rev/Ver AC 
 
 
Page 14 of 36 
o Length of procedures 
o Number of devices 
5. Design 
The study is designed as a post-market, multi-center, prospective, non-blinded, randomized 
study. At least 164 subjects (82 per arm) will be treated with 1:1 randomization between 
Group A and Group B and will be followed through 24 months post-initial stent(s) 
placement:  
 Subjects in the MS arm will be treated with a single metal stent, which will be 
removed 12 months post-placement.  
 Subjects in the PS arm will receive 2 plastic stents when possible. Subjects in this arm 
will undergo plastic stents exchange/bile duct calibration at 4 and 8 month post-initial 
stent placement. At each stent exchange, the goal should be to provide progressive 
stent therapy by increasing the number of plastic stents at 4 months and again at 8 
months. Final plastic stent removal will occur 12 months post-initial stent placement.  
5.1. Inclusion Criteria: 
 Age 18 or older 
 Willing and able to comply with the study procedures and provide written informed 
consent to participate in the study 
 Chronic pancreatitis 
 Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at 
least one month or cholestasis associated with at least 3 times normal alkaline 
phosphatase levels) documented at time of enrollment for naïve stricture or at the 
time of prior plastic stent placement in strictures that had one prior plastic stent 
inserted.12 
 Common bile duct stricture based on imaging assessment of dilatation of the common 
and/or intrahepatic bile ducts 
5.2. 
Exclusion Criteria: 
 Biliary stricture of benign etiology other than chronic pancreatitis  
 Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or 
less for 6 months or fewer 
 Developing obstructive biliary symptoms associated with an attack of acute 
pancreatitis  
 Biliary stricture of malignant etiology 
 Stricture within 2 cm of common bile duct bifurcation 
 Known bile duct fistula or leak 
 Subjects for whom endoscopic techniques are contraindicated 
 Known sensitivity to any components of the stent or delivery system 
 Symptomatic duodenal stenosis (with gastric stasis) 
 Participation in another investigational study within 90 days prior to consent  

 
 
Confidential 
February 15, 2013 
 
Boston Scientific 
FINAL 
 WallFlex Biliary FC Chronic Pancreatitis RCT Protocol 
 
 
90913882 Rev/Ver AC 
 
 
Page 15 of 36 
 Investigator Discretion 
6. Subject Accountability 
6.1. 
Point of Enrollment 
A subject is considered enrolled after signing the Informed Consent Form (ICF). See Section 
8.4 for further information on enrolled, intent-to-treat and per-protocol cohorts.  
6.2. 
Withdrawal 
All subjects enrolled in the clinical study (including those withdrawn from the clinical study 
or lost to follow-up) shall be accounted for and documented. If a subject withdraws from the 
clinical investigation, the reason(s) shall be reported and recorded in the study database. If 
such withdrawal is due to problems related to investigational device safety or performance, 
the investigator shall ask for the subject’s permission to follow his/her status/condition 
outside of the clinical study.  
While study withdrawal is discouraged, subjects may withdraw from the study at any time, 
with or without reason, and without prejudice to further treatment. Additional data may no 
longer be collected after the point at which a subject has been withdrawn from the study or 
withdraws consent. Withdrawn subjects will not be replaced. All open adverse events should 
be closed or documented as ongoing. Data collected up to the point of subject withdrawal 
may still be used. 
7. Study Methods 
7.1. 
Data Collection 
The schedule of observations and assessments to take place during the study follows on the 
next page. 

 
 
 
 
 
 
Confidential 
January 17, 2012 
Boston Scientific 
FINAL 
 WallFlex Biliary FC Chronic Pancreatitis RCT Protocol 
 
90913882 Rev/Ver AC 
 
 
Page 16 of 36 
 
 
 
Table 1.  Study Event Schedule 
Study Visit 
Screening/ 
Baseline 
Treatment 
Mo. 1* 
(30 d) 
Mo. 4 
(120 d) 
Mo. 8 
(240 d) 
Mo. 11-12  
(330-360 d) 
Mo 24*  
(720 d) 
 Additional 
ERCP 
Window 
≤ 5 days 
prior to 
treatment 
N/A 
±10 d 
±30 d 
±30 d 
See range 
above 
±30 d 
NA 
ICF 
X 
 
 
 
 
 
 
 
Eligibility Assessment 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
 
Liver Function Normal Ranges 
X** 
 
 
 
 
 
X 
X**** 
Liver Function Tests 
X 
 
X 
*** 
*** 
X 
X 
X 
Assessment of Biliary 
Obstructive Symptoms 
X 
 
X 
 
 
X 
X 
X**** 
Randomization 
 
X 
 
 
 
 
 
 
Stent Placement/Exchange 
 
X 
 
PS Only 
PS Only 
 
 
X (if done) 
Stent Removal 
 
 
 
 
 
X 
 
 
Cholangiogram or other 
Common Bile Duct Imaging 
X (prior to stent placement) 
 
 
 
X (after stent 
removal) 
 
X 
(if standard of 
practice) 
AE/Device Malfunction 
Assessment 
Report as occurs/needed per the Protocol Reporting Requirements – See Section 11. 
Protocol Deviations 
Report as occurs/needed. 
*Visit may be conducted in the office or via telephone with liver function tests drawn and sent from local clinic/hospital. 
**In addition to baseline LFTs, LFTs are also to be collected from time of original plastic stent placement for any subject with a prior plastic stent.   
***If subject is not re-stented after Month 4 or 8 Plastic Stent Exchange, Liver Function Tests must be collected at that visit. 
****Required for any visit that results in re-stenting 

 
Febru
FINA
 
 
7.2. 
No st
Scree
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7.3. 
Writt
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must 
Study
signs
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7.4. 
7.4.1
uary 15, 2013 
AL 
Study Ca
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Informed
ten Informed
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be approved
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 the ICF, the
idate for the 
Study Vi
 Screening
.
placemen
 Inform
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plastic ste
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 Adver
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d Consent 
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procedures ar
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should expla
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isits 
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med Consent
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cal History 
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Alkaline p
Total Bilir
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SGOT and
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Right Upp
Fever/Chil
Jaundice 
Itching 
Dark urine
Pale stools
Nausea/Vo
angiogram or
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l be conduct
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asked to sign
re performed
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ain that even
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– Visits/Asse
Visit 
t (See Sectio
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ests (at enrol
nt in stricture
phosphatase –
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essments m
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aïve stricture
one prior pla
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ssment 
ronic Pancreat
9091
t has signed 
enter to docu
are potentia
form before 
nt form is stu
)/Ethics Com
articipate in 
bject is not a
within 5 days
es or at the ti
astic stent ins
 
Confidentia
Boston Scie
titis RCT Pro
13882 Rev/Ve
Page 17
an ICF. A 
ument select
al study 
any study-
udy-specific
mmittee (EC)
the study an
a suitable 
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Febru
FINA
 
 
7.4.2
7.4.3
7.4.4
7.4.5
7.4.6
7.4.7
uary 15, 2013 
AL 
 Randomi
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 Plastic St
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 Post-Sten
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subject has s
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he subject w
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angiogram or
Placement P
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tent Exchan
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Stent Remo
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es containin
mon Bile Du
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nction Asses
p (Month 1)
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4 and 8 – P
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Month 12) –
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Review Boar
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assignments
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) – Office or
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PS Only) – O
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Liver Funct
– Office Visit
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4) – Office or
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9091
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(prior to ste
8.5 or 10 Fr. 
r Telephone 
ection 7.4.1)
Office Visit 
tion Tests mu
t 
(post-stent r
r Telephone
Confidentia
Boston Scie
titis RCT Pro
13882 Rev/Ve
Page 18
lusion criteri
hics Commit
of the exclu
n schedules w
generator and
ained from t
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atio to receiv
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Febru
FINA
 
 
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uary 15, 2013 
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up. The null 
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with a metal 
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stent placem
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r to the Plasti
ture resoluti
is that the rat
Stent Arm: 
Confidentia
Boston Scie
titis RCT Pro
13882 Rev/Ve
Page 19
sit that resul
isit that resu
collected in 
oup A (MS) 
rent stricture
Group B (PS
ement for al
for the MS a
ance with 
sidered lost t
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Febru
FINA
 
 
 
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uary 15, 2013 
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Analysis Plan
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Confidentia
Boston Scie
titis RCT Pro
13882 Rev/Ve
Page 20
the metal ste
y margin. 
est using SA
al stent group
ability of a 
ich was take
(∆) is 20%. 
48 subjects w
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Febru
FINA
 
 
8.4.2
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uary 15, 2013 
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baseline char
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mber of obser
Comparabi
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andard statis
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ariables and 
ndpoints will
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Across Insti
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frequency st
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on endpoints
or Kaplan-M
tutions 
d using data p
 WallFlex Bi
subjects who
cts in this co
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d. Protocol d
e ITT subject
itions). 
pothesis test
ent placemen
have reached 
g The SAS S
AS Campus 
graphics, cli
ariables will 
 standard de
statistics (pe
discrete var
mong center
Any significa
cted at regul
nd will be su
tatistics for d
d by treatmen
nce intervals.
s will be ana
Meier method
pooled across
iliary FC Chr
o meet all inc
ohort who do
adverse even
deviations w
ts who recei
ting) once th
nt.  
d 24 months p
System softw
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ercent of con
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rs and betwe
ant differenc
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discrete vari
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. 
alyzed using
ds per sectio
s institutions
ronic Pancreat
9091
clusion/excl
o not receive
nts occurring
will be collec
ive a study s
he first 50 su
post initial s
ware, version
y, North Caro
y, risk factor
ized using de
mber of obse
nformers, nu
een treatmen
ces will be id
led follow-u
using descrip
iables. Estim
well as diffe
g logistic regr
on 8.6.1 and 
s and poolabi
Confidentia
Boston Scie
titis RCT Pro
13882 Rev/Ve
Page 21
usion criteri
e a study sten
g or resultin
cted as neces
tent(s) and n
ubjects have 
stent placem
n 8 or higher
olina 27513,
rs, pre- and p
escriptive 
ervations, 
umber of 
nts will be 
dentified and
up examinati
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mates of prim
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the SAP. 
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no 
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ween 

 
 
Confidential 
February 15, 2013 
 
Boston Scientific 
FINAL 
 WallFlex Biliary FC Chronic Pancreatitis RCT Protocol 
 
 
90913882 Rev/Ver AC 
 
 
Page 22 of 36 
9. Data Management 
9.1. 
Data Collection, Processing, and Review 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system.  
The clinical database will reside on a production server hosted by Medidata. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by Boston Scientific Corporation (BSC) or its representative. The associated RAVE software 
and database have been designed to meet regulatory compliance for deployment as part of a 
validated system compliant with laws and regulations applicable to the conduct of clinical 
studies pertaining to the use of electronic records and signatures. Database backups are 
performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the EDC system and will 
be issued to the site for appropriate response. Site staff will be responsible for resolving all 
queries in the database. 
9.2. 
Data Retention 
The Investigator will maintain, at the investigative site, in original format all essential study 
documents and source documentation that support the data collected on the study subjects in 
compliance with ICH/GCP guidelines. Documents must be retained for at least 2 years after 
the last approval of a marketing application or until at least 2 years have elapsed since the 
formal discontinuation of the clinical investigation of the product. These documents will be 
retained for a longer period of time by agreement with BSC or in compliance with other local 
regulations. It is BSC’s responsibility to inform the Investigator when these documents no 
longer need to be maintained. The Investigator will take measures to ensure that these 
essential documents are not accidentally damaged or destroyed. If for any reason the 
Investigator withdraws responsibility for maintaining these essential documents, custody 
must be transferred to an individual who will assume responsibility, and BSC must receive 
written notification of this custodial change.  
10. Potential Risks and Benefits 
10.1. Anticipated Adverse Device Effects  
As per the commercial DFU included with the study devices, the potential complications 
associated with metal stent placement include, but are not limited to:  

 
 
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 Pain 
 Bleeding 
 Fever 
 Nausea 
 Vomiting 
 Infection 
 Inflammation 
 Stent occlusion 
 Tumor overgrowth around ends of stent 
 Tumor ingrowth through the stent 
 Mucosal hyperplasia 
 Cholangitis 
 Cholecystitis* 
 Pancreatitis 
 Ulceration of duodenum or bile duct 
 Perforation of duodenum or bile duct 
 Stent migration 
 Death (other than that due to normal disease progression) 
 Stent misplacement 
 Perforation of the gallbladder due to the stent covering the cystic duct* 
 Stent Fracture 
 Hepatic abscess 
*Note: In a small clinical trial of this device, two out of four (50%) subjects who had 
a stent placed across the cystic duct developed cholecystitis. One of these subjects 
suffered a perforated gallbladder due to the stent covering the cystic duct, requiring a 
drain to be placed. 
 
As per the commercial DFU included with the study devices, potential complications 
associated with stent removal include, but are not limited to:  
 Pain 
 Bleeding 
 Fever 
 Nausea 
 Vomiting 
 Infection 
 Inflammation 
 Recurrent obstructive jaundice 
 Mucosal hyperplasia 
 Cholangitis 
 Cholecystitis 
 Pancreatitis 
 Ulceration of duodenum or bile duct 
 Perforation of duodenum or bile duct 

 
 
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 Death (other than that due to normal disease progression) 
 Impaction to the common bile duct wall 
 
The following specific definitions will be used: 
 Pancreatitis: Abdominal pain and a serum concentration of pancreatic enzymes 
(amylase or lipase) three or more times the upper limit of normal, that required more 
than one night of hospitalization 
 Cholecystitis: No suggestive clinical or radiographic signs of cholecystitis before the 
procedure and if emergency cholecystectomy is subsequently required 
 Perforation: Retroperitoneal or bowel-wall perforation documented by any 
radiographic technique or direct visual evidence 
 Stent Occlusion: Recurring obstructive jaundice with necessary stent replacement 
 Hepatic Abscess: Intra-hepatic fluid collection with positive cultures identified when 
possible by ultrasonography or computed tomography, associated with persistent 
fever and elevations of white blood cells 
 Cholangitis: Elevation in temperature more than 38°C, thought to have a biliary 
cause, without concomitant evidence of acute cholecystitis, requiring intervention 
 Bleeding: Bleeding requiring endoscopic hemostatic intervention and/or transfusion  
 
10.2. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
10.3. Anticipated Benefits 
Subjects may not receive any benefit from participating in this study. However, medical 
science and future subjects may benefit from this study.  
10.4. Risk to Benefit Rationale 
Based on prior BSC clinical studies and collected reports in literature to-date, the risk-to-
benefit ratio is within reason for foreseeable risks. However, literature reports do not always 
capture all side effects. Observation and follow-up of subjects is required as outlined in the 
protocol. 
11. Safety Reporting 
11.1. Definitions and Classification 
Adverse event definitions are provided in Table 11.1-1. 
Table 11.1-1: Adverse Event Definitions 
Term 
Definition 

 
 
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Table 11.1-1: Adverse Event Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155-2011 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal lab findings) in subjects, users 
or other persons, whether or not related to the investigational medical 
device. This includes events related to: 
 The investigational medical device or comparator 
 The procedures involved (study-required) 
For users/other persons, this definition is restricted to events related to the 
investigational device  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155-2011 
Adverse event related to the use of an investigational medical device: 
 This includes adverse events resulting from insufficient or inadequate 
instructions for the use, deployment, implantation, installation or 
operation, or any malfunction of the investigational medical device. 
 This includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155-2011 
An adverse event that: 
 Led to death 
 Led to a serious deterioration in the health of the subject that either 
resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient hospitalization or prolonged hospitalization (of an existing 
hospitalization), or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function 
 Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
Note: Planned hospitalization for a pre-existing condition, or a procedure 
required by the protocol, without serious deterioration in health, is not 
considered a serious adverse event.  
Note: For SAE reporting requirements see the information below for SADE. 
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155-2011 
An adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Note: All SAEs that could have led to a SADE if suitable action had not 
been taken or if circumstances had been less fortunate shall be reported as 
required by the local IRB/EC, national regulations, or the protocol. If 
applicable, see MEDDEV 2.7/3 12/2010 for reporting timeline 
requirements. 
Device Deficiency 
 
Ref: ISO 14155-2011 
 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
Note: Device deficiencies include malfunctions, use errors, and inadequate 
labeling. 
Note: All device deficiencies that could have led to a SADE if suitable 
action had not been taken or if circumstances had been less fortunate shall 
be reported as required by the local IRB/EC, national regulations, or the 

 
 
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Table 11.1-1: Adverse Event Definitions 
Term 
Definition 
protocol. If applicable, see MEDDEV 2.7/3 12/2010 for reporting timeline 
requirements. 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be recorded as an AE, but 
should only be reflected as an outcome of a specific SAE (see Table 11.1-1 for AE 
definitions).  
Any AE experienced by the study subject after informed consent, whether during or 
subsequent to the procedure, must be recorded in the eCRF. 
Refer to Section 10.1 for the known risks associated with the study device(s). 
11.2. Relationship to Study Device(s) 
The Investigator must assess the relationship of the AE to the study device as related or 
unrelated. See criteria in Table 11.2-1. 
Table 11.2-1: Criteria for Assessing Relationship of Study Device to Adverse Event 
Classification 
Description 
Unrelated 
The adverse event is determined to be due to a concurrent illness or effect of another 
device/drug and is not related to the investigational product. 
Related 
 The adverse event is determined to be potentially related to the investigational 
product, and an alternative etiology is equally or less likely compared to the 
potential relationship to investigational product. 
 There is a strong relationship to investigational product, or recurs on re-challenge, 
and another etiology is unlikely. 
 There is no other reasonable medical explanation for the event. 

 
Febru
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13. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days.  
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor via the EDC CRF page in the 
database. Site may also be required to report deviations to the IRB/EC, per local guidelines 
and government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the sponsor. 
14. Device/Equipment Accountability 
There are no investigational devices used in this study. The WallFlex Biliary RX Fully 
Covered Stent System is available for commercial use in the geographic areas in which this 
clinical study is taking place; therefore, there is no requirement for device accountability for 
the purposes of this study. Device lot information must be maintained in the subject’s 
medical record and recorded on the appropriate case report form.  
Any individual country/region requirements that depart from the aforementioned will be 
implemented on a case-by-case basis. 
15. Compliance 
15.1. Statement of Compliance 
This study will be conducted in accordance with relevant sections of the International 
Standard (ISO) 14155: Clinical Investigation of Medical devices for Human Subjects – Good 
Clinical Practice, the relevant parts of the ICH Guidelines for Good Clinical Practices, ethical 
principles that have their origins in the Declaration of Helsinki, and pertinent individual 
country laws and regulations. The study will not begin until the required approval/favorable 
opinion from the EC and/or regulatory authority has been obtained, if appropriate. Any 
additional requirements imposed by the EC or regulatory authority shall be followed,                     
if appropriate. 
15.2. Investigator Responsibilities 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 

 
 
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Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing local 
and/or country laws and/or regulations, whichever affords the greater protection to the 
subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  
 Prior to study start, sign the Investigator Agreement and Protocol Signature page 
documenting his/her agreement to conduct the study in accordance with the protocol. 
 Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
 Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
 Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
 Ensure the accuracy, completeness, legibility and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
 Record, report and assess (seriousness and relationship to the device/procedure) every 
adverse event and observed device deficiency. 
 Report to BSC, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE. 
 Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies that 
could have led to a SADE, if required by the national regulations or this protocol or by 
the IRB/EC, and supply BSC with any additional requested information related to the 
safety reporting of a particular event. 
 Maintain the device accountability records and control of the device, per local 
requirements, ensuring that the investigational device is used only by 
authorized/designated users and in accordance with this protocol and 
instructions/directions for use. 
 Allow the sponsor to perform monitoring and auditing activities and be accessible to the 
monitor and respond to questions during monitoring visits. 
 Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
 Ensure that informed consent is obtained in accordance with this protocol and local 
IRB/EC requirements. 

 
Febru
FINA
 
 
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Confidentia
Boston Scie
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articipation i
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A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the study and shipment of investigational 
product/equipment. Prior approval must also be obtained for other materials related to subject 
recruitment or which will be provided to the subject. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the study 
as required by local/country or IRB/EC requirements. Copies of the Investigator’s reports 
and the IRB/EC continuance of approval must be provided to the sponsor.  
15.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative will have access to these confidential records. Authorized regulatory personnel 
have the right to inspect and copy all records pertinent to this study. Study data collected 
during this study may be used by BSC for the purposes of this study, publication and to 
support future research and/or other business purposes. All data used in the analysis and 
reporting of this study will be without identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ health information confidential in accordance with all 
applicable laws and regulations. Boston Scientific may use subjects’ health information to 
conduct this research, as well as for additional purposes, such as overseeing and improving 
the performance of its device, new medical research and proposals for developing new 
medical products or procedures, and other business purposes. Information received during 
the study will not be used to market to subjects; subject names will not be placed on any 
mailing lists or sold to anyone for marketing purposes.  
15.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
16. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the monitor verifies that study records are 
adequately maintained, that data are reported in a satisfactory manner with respect to 
timeliness, adequacy, and accuracy and that the Investigator continues to have sufficient staff 
and facilities to conduct the study safely and effectively. The Investigator/institution 
guarantees direct access to original source documents by BSC personnel, their designees and 
appropriate regulatory authorities. 
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 

 
 
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17. Informed Consent 
Subject participation in this clinical study is voluntary. Informed Consent is required from all 
subjects or their legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 
approved by the center’s IRB/EC, or central IRB, if applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative center’s IRB/EC. Any modification requires approval from BSC prior to use of 
the form. The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the center in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC approval prior to their use. Privacy language shall be included in the 
body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall be conducted as follows: 
 conducted by the Principal Investigator or designee authorized to conduct the process,  
 include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
 avoid any coercion of or undue influence of subjects to participate, 
 not waive or appear to waive subject’s legal rights, 
 use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
 provide ample time for the subject to consider participation and ask questions if 
necessary, 
 ensure important new information is provided to new and existing subjects throughout the 
clinical study. 
The ICF shall always be signed and personally dated by the subject or legal representative 
and by the investigator or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the center and a copy of the signed and dated document and 
any other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements. Any violations of the informed consent process must be 
reported as deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as 
appropriate. 

 
 
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If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the protocol, a change in Principal Investigator, administrative changes, or following 
annual review by the IRB/EC. The new version of the ICF must be approved by the IRB/EC. 
Boston Scientific approval is required if changes to the revised ICF are requested by the 
center’s IRB/EC. The IRB/EC will determine the subject population to be re-consented. 
18. Suspension or Termination 
23.1 Premature Termination of the Study 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and reasons 
related to protection of subjects. Investigators, associated IRBs/ECs, and regulatory 
authorities, as applicable, will be notified in writing in the event of study termination. 
23.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following: 
 The occurrence of unanticipated adverse device effects that present a significant or 
unreasonable risk to subjects enrolled in the study. 
 An enrollment rate far below expectation that prejudices the conclusion of the study.  
 A decision on the part of Boston Scientific to suspend or discontinue development of the 
device. 
23.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
Any investigator, or IRB/ EC may discontinue participation in the study or withdrawal 
approval of the study, respectively, with suitable written notice to Boston Scientific. 
Investigators, associated IRBs/ECs, and regulatory authorities, as applicable, will be notified 
in writing in the event of these occurrences. 
23.3 Requirements for Documentation and Subject Follow-up 
In the event of premature study termination, a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston Scientific. 
The IRB/EC and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  

 
 
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In the event an IRB or EC terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be provided 
by Boston Scientific. 
In the event an investigator terminates participation in the study, study responsibility will be 
transferred to a co-investigator, if possible. In the event there are no opportunities to transfer 
investigator responsibility, detailed information on how enrolled subjects will be managed 
thereafter will be provided by Boston Scientific. 
The investigator must return all documents and investigational product to Boston Scientific, 
unless this action would jeopardize the rights, safety, or welfare of the subjects. 
23.4 Criteria for Suspending/Terminating a Study Center 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a study 
center at any time after the study initiation visit if no subjects have been enrolled for a period 
beyond 2 months after center initiation or if the center has multiple or severe protocol 
violations/non-compliance without justification and/or fails to follow remedial actions. In the 
event of termination of investigator participation, the EC, as applicable, should be notified.  
19. Publication Policy 
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. In accordance with the Corporate Policy 
for the Conduct of Human Subject Research, BSC will submit study results for publication 
(regardless of study outcome) following the conclusion or termination of the study. Boston 
Scientific Corporation adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed. 
 All authorship and contributorship requirements as described above must be followed. 
 BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
 The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
 
 

 
 
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20. Bibliography 
1. Behm, B, Brock A, Clark BW, et al. Partially covered self-expandable metallic stents 
for benign biliary strictures due to chronic pancreatitis. Endoscopy 2009; 41: 547-
5571  
2. Kahl S, Zimmermann S, Glasbrenner, et al. Treatment of Benign Biliary Strictures in 
Chronic Pancreatitis by Self-Expandable Metal Stents. Digestive Disease 2002;20: 
199-203  
3. Catalano MF, Linder JD, Suku G. Treatment of symptomatic distal common bile 
duct stenosis secondary to chronic pancreatitis: comparison of single vs. multiple 
simultaneous stents. Gastrointest Endosc 2004;60:945-952 
4. Eickoff A, Jakobs R, Leonhardt A, Eickoff JC, Riemann JF.  Endscopic stenting for 
common bile duct stenoses in chronic pancreatitis: results and impact on long-term 
outcome.  Euro J Gastroenterol Hepatol 2001;13:1161-1167 
5. Cahen DL, van Berkel AM, Oskam D. et al. Long-term results of endoscopic 
drainage of common bile duct strictures in chronic pancreatitis. Euro J Gastroenterol 
Hepatol 2005;17:103-108 
6. Sakai Y, Tsuyuguchi T, Ishihara T. Long-term prognosis of patients with 
endoscopically treated postoperative bile duct stricture and bile duct stricture due to 
chronic pancreatitis. J Gastroenterol Hepatol 2009;24:1191-1197 
7. Costamagna G, Pandolfi M, Mutignani M, et al. Long-term results of endoscopic 
management of postoperative bile duct strictures with increasing number of stents.  
Gastrointestinal Endoscopy 2001;54:162-168 
8. Draganov P, Hoffman B, Marsh W, et al. Long-term outcomes in patients with 
benign biliary strictures treated endoscopically with multiple stents. Gastrointest 
Endosc 2002;55:680-686 
9. Kahaleh M, Behm B, Clarke BW, et al. Yeaton P. Temporary placement of covered 
self-expanding metal stents in benign strictures: a new paradigm? Gastrointest Endosc 
2008;67:446-54 
10. Mahajan A, Ho HC, Brock AS, et al. Temporary placement of fully covered self-
expandable metal stents in benign biliary strictures: midterm evaluation (with video).  
Gastrointest Endosc 2009;70:303-309. 
11. Park D, Sang Soo L, Hoon Lee T, et al. Anchoring flap versus flared end, fully 
covered self-expandable metal stents to prevent migration in patients with benign 
biliary strictures: a multicenter, prospective, comparative pilot study (with videos). 
Gastrointest Endosc 2011;73: 64-70 
12. Abdallah A, Krige, J, Bornman, P. Biliary tract obstruction in chronic pancreatitis. 
HPB 2007; 9: 421-428. 
13. SAS Institute Inc. SAS for Windows, version 9. SAS Institute Inc. : Cary, NC,     
U.S.A., 2003. 
 

 
 
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21. Abbreviations and Definitions  
Acronym 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ALT 
Alanine Aminotransferase 
AST 
Aspartate Aminotransferase  
BSC 
Boston Scientific Corporation 
CRF  
Case Report Form 
CT 
Computed Tomography 
DFU 
Directions for Use 
eCRF 
EC 
Electronic Case Report Form 
Ethics Committee 
EDC 
Electronic Data Capture 
ERCP 
Endoscopic Retrograde Cholangiopancreatography 
FDA 
Food and Drug Administration 
Gamma GT 
Gamma-Glutamyl Transpeptidase 
GCP 
Good Clinical Practices 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
ISO 
International Standards Organization 
LFT 
MS 
Liver Function Test 
Metal Stent 
PI 
Plastic Stent 
Principal Investigator 
Plastic Stent 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SEMS 
Self-Expanding Metal Stent 
SGOT 
Serum Glutamic Oxaloacetic Transaminase 
SGPT 
Serum Glutamic Pyruvic Transaminase