Shark Mouth Modified Pancreaticojejunostomy in Pancreaticoduodenectomy Procedure
Conditions: Pancreatic Cancer, Periampullary Carcinoma
Sponsor: Peking University Third Hospital

Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 Shark Mouth Modified Pancreaticojejunostomy（SMMP） in 
Pancreaticoduodenectomy Procedure   
 
 
 
 
 
 
National Clinical Trial (NCT) Identified Number:  
 
 
Principal Investigator: Dianrong Xiu 
 
Organization: Department of General Surgery, Peking University Third Hospital 
 
 
 Version Number:  v.<20171101> 
<01 Nov 2017> 
 
 
 
 
 
 
 
 
 

Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 2 
1.1 
Synopsis ................................................................................................................................................ 2 
1.2 
Schema ................................................................................................................................................. 3 
1.3 
Schedule of Activities (SoA) ............................................................................................................... 4 
2 
INTRODUCTION ............................................................................................................................................ 5 
2.1 
Study Rationale .................................................................................................................................... 5 
2.2 
Background ........................................................................................................................................... 5 
2.3 
Risk/Benefit Assessment .................................................................................................................... 6 
2.3.1 
Known Potential Risks ..................................................................................................... 6 
2.3.2 
Known Potential Benefits ................................................................................................ 6 
2.3.3 
Assessment of Potential Risks and Benefits ................................................................ 6 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................................ 6 
4 
STUDY DESIGN ............................................................................................................................................. 7 
4.1 
Overall Design ...................................................................................................................................... 7 
4.2 
End of Study Definition ....................................................................................................................... 7 
5 
STUDY POPULATION .................................................................................................................................. 7 
5.1 
Inclusion Criteria .................................................................................................................................. 7 
5.2 
Exclusion Criteria ................................................................................................................................. 7 
5.3 
Screen Failures .................................................................................................................................... 8 
5.4 
Strategies for Recruitment and Retention ........................................................................................ 8 
6 
STUDY INTERVENTION .............................................................................................................................. 8 
6.1 
Study Intervention(s) Administration ................................................................................................. 8 
6.1.1 
Study Intervention Description ....................................................................................... 8 
6.2 
Study Intervention Compliance .......................................................................................................... 8 
6.3 
Concomitant Therapy .......................................................................................................................... 8 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ...................................................................................................................... 9 
7.1 
Discontinuation of Study Intervention ............................................................................................... 9 
7.2 
Participant Discontinuation/Withdrawal from the Study ................................................................. 9 
7.3 
Lost to Follow-Up ................................................................................................................................. 9 
8 
STUDY ASSESSMENTS AND PROCEDURES ........................................................................................ 9 
8.1 
Efficacy Assessments ......................................................................................................................... 9 
8.2 
Safety and Other Assessments ....................................................................................................... 10 
8.3 
Adverse Events and Serious Adverse Events ............................................................................... 10 
8.3.1 
Definition of Adverse Events (AE) ............................................................................... 10 
8.3.2 
Definition of Serious Adverse Events (SAE) .............................................................. 10 
8.3.3 
Classification of an Adverse Event .............................................................................. 10 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ....................... 11 
8.3.5 
Adverse Event Reporting .............................................................................................. 12 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 12 
8.3.7 
Reporting of Pregnancy ................................................................................................ 12 
8.4 
Unanticipated Problems .................................................................................................................... 12 
8.4.1 
Definition of Unanticipated Problems (UP) ................................................................. 12 

Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
8.4.2 
Unanticipated Problem Reporting ................................................................................ 13 
9 
STATISTICAL CONSIDERATIONS .......................................................................................................... 13 
9.1 
Statistical Hypotheses ....................................................................................................................... 13 
9.2 
Sample Size Determination .............................................................................................................. 14 
9.3 
Populations for Analyses .................................................................................................................. 14 
9.4 
Statistical Analyses ............................................................................................................................ 14 
9.4.1 
General Approach .......................................................................................................... 14 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 14 
9.4.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 15 
9.4.4 
Safety Analyses .............................................................................................................. 15 
9.4.5 
Baseline Descriptive Statistics ..................................................................................... 15 
9.4.6 
Sub-Group Analyses ..................................................................................................... 15 
9.4.7 
Tabulation of Individual participant Data .................................................................... 15 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 15 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 15 
10.1.1 
Informed Consent Process ........................................................................................... 15 
10.1.2 
Study Discontinuation and Closure ............................................................................. 16 
10.1.3 
Confidentiality and Privacy ........................................................................................... 17 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 17 
10.1.5 
Key Roles and Study Governance .............................................................................. 18 
10.1.6 
Safety Oversight ............................................................................................................. 18 
10.1.7 
Clinical Monitoring .......................................................................................................... 18 
10.1.8 
Quality Assurance and Quality Control ....................................................................... 19 
10.1.9 
Data Handling and Record Keeping ............................................................................ 19 
10.1.10 
Protocol Deviations ........................................................................................................ 20 
10.1.11 
Publication and Data Sharing Policy ........................................................................... 20 
10.1.12 
Conflict of Interest Policy .............................................................................................. 20 
10.2 
Abbreviations ...................................................................................................................................... 21 
10.3 
Protocol Amendment History ........................................................................................................... 23 
11 
REFERENCES ............................................................................................................................................. 24 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
1 
STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and 
the <specify NIH Institute or Center (IC) > Terms and Conditions of Award. The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the Investigational New Drug (IND) or Investigational Device 
Exemption (IDE) sponsor, funding agency and documented approval from the Institutional 
Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial 
participants. All personnel involved in the conduct of this study have completed Human Subjects 
Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval.  Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study.  All 
changes to the consent form will be IRB approved; a determination will be made regarding 
whether a new consent needs to be obtained from participants who provided consent, using a 
previously approved consent form. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
2 
1 
 
PROTOCOL SUMMARY 
 
1.1 
SYNOPSIS  
Title: 
Shark Mouth Modified Pancreaticojejunostomy（SMMP） in 
Pancreaticoduodenectomy Procedure 
Study Description: 
We established a new digestive reconstruction technique named SMMP, 
which had theoretical advantages including easier performed; lower 
tension and less complication. The pancreaticojejunostomy time, post-
operation complication, mortality and hospital stay will be documented to 
study the safety, efficiency and advantage of this new procedure.  
Objectives: 
 
 
Primary Objective:  To evaluate the new procedure (SMMP) 
 
Secondary Objectives:   To popularize SMMP 
Endpoints: 
Primary Endpoint: pancreatic fistula 
Secondary Endpoints: Mortality ; Morbidity ; pancreaticojejunostomy 
time ; Hospital stay  
Study Population: 
120 cases of Chinese Patients diagnosed with pancreatic cancer or other 
diseases which need pancreaticoduodenectomy;  any gender; 18-80 years 
old 
Phase: 
N/A 
Description of 
Sites/Facilities Enrolling 
Participants: 
 Department of General Surgery, Peking University Third Hospital 
Description of Study 
Intervention: 
The remnant of jejunum is closed by continuous suture. The transverse 
incision is made on the posterior wall of the jejunum (5 centimeters distal 
to remnant）, which starts at 0.2 centimeter to the mesenteric border and 
should never exceed the anti-mesenteric border. In case of large pancreas 
remnant, a longitudinal jejunum incision will be done at anterior part of 
anastomosis. The posterior part of anastomosis is two layers of 
intermittent suture, including seromuscular suture layer and full thickness 
suture layer. The anterior part of anastomosis is a single layer full thickness 
suture. At last, the seromuscular layer of the proximal jejunum is sutured 
with the anterior pancreatic capsule to cover the anterior part of 
anastomosis. 
Study Duration: 
December, 2017   To December, 2019    
Participant Duration: 
3 months 
 
 
 
 
 
 
 
 
 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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1.2 
SCHEMA 
This section should include a diagram that provides a quick “snapshot” of the study and ideally be limited 
to 1 page. Below are examples of schematics that show the level of detail needed to convey an overview 
of the study design. Depending on the nature of your study, one example may be more appropriate than 
another.  Regardless, the examples included here are intended to guide the development of a schematic 
that is appropriate to the planned study design and will need to be customized for the protocol. Revise 
with study-specific information and adapt the diagram to illustrate your study design (e.g., changing 
method of assignment to study group, adding study arms, visits, etc.). The time point(s) indicated in the 
schematic should correspond to the time point(s) in Section 1.3, Schedule of Activities, e.g., Visit 1, Day 0; 
Visit 2, Day 30 ± 7; etc.    
Process diagram 
 
 
 
Screening
Week-1
•Total n=120
•Obtain informed consent
•Screen potential participants by inclusion and exclusion criteria
•Obtain history, document
Operation
Day 0
•Intervention Group  (n=120)
Day 1
•Phy examinations;Vital signs; Blood routine test;Serum chemistry; drainage quality and quantity; drainaige 
amylase; drainage bacteria culture
Follow-up assessments of study endpoints and safety
Day 3
•Phy examinations;Vital signs; Blood routine test;Serum chemistry; drainage quality and quantity; drainaige 
amylase; drainage bacteria culture
Follow-up assessments of study endpoints and safety
Day 7
•Phy examinations;Vital signs; Blood routine test;Serum chemistry; drainage quality and quantity; drainaige 
amylase; drainage bacteria culture
End of Study Assessments
Day 90
•Phy examinations;Vital signs;  Blood routine test;Serum chemistry;the situation of drainage and wound
Follow-up assessments of study endpoints and safety

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
4 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Procedures 
Screening 
Day -7 to -1 
Operation 
Visit 1, Day 0 
Visit 2  
Day 1 
Visit 3 
Day3 
Visit 4 
Day 7 
Final Visit 5 
Day 90 +/-3 
day  
Informed consent 
X 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
Physical exam (including 
height and weight) 
X 
X 
X 
X 
X 
X 
Vital signs 
X 
X 
X 
X 
X 
X 
Performance status 
X 
X 
X 
X 
X 
X 
Hematology  
X 
X 
X 
X 
X 
X 
serum chemistry a 
X 
X 
X 
X 
X 
X 
Pregnancy test b 
X 
 
 
 
 
 
Trial intervention 
 
X 
 
 
 
 
Intraoperative outcomes c 
 
X 
 
 
 
 
drainage quality 
 
 
X 
X 
X 
X 
drainage quantity 
 
 
X 
X 
X 
X 
drainaige amylase 
 
 
X 
X 
X 
 
drainage bacteria culture 
 
 
X 
X 
X 
 
Adverse event review and 
evaluation 
 
X 
X 
X 
X 
X 
Complete Case Report Forms 
(CRFs) 
X 
X 
X 
X 
X 
X 
a:Albumin, alkaline phosphatase, total bilirubin, bicarbonate, BUN, calcium, chloride, creatinine, glucose, LDH, phosphorus, potassium, 
total protein, AST, ALT, sodium. 
b:Urine pregnancy test (women of childbearing potential). 
c: pancreaticojejunostomy time; operative course, final pathology, gland texture, pancreatic duct diameter, size of the stent, length of 
pancreatic juice in the stent tube, width of the pancreatic stump and diameter of the jejunum 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
5 
2 
 
INTRODUCTION 
 
 
2.1 
STUDY RATIONALE  
 
Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the 
standard treatments for benign and malignant disease of pancreatic head and periampullary region. The 
key point of PD is still the enteric reconstruction of pancreatic stump. We established a new digestive 
reconstruction technique named shark mouth modified pancreaticojejunostomy, which had theoretical 
advantages including easier performed; lower tension and less complication. So we conduct this trial to 
evaluate this procedure. 
 
2.2 
BACKGROUND  
Pancreaticoduodenectomy (PD) is one of the most complicated surgical procedure and one of the 
standard treatments for benign and malignant disease of pancreatic head and periampullary region. 
Improvements in surgical techniques and the perioperative management of patients undergoing PD 
have reduced the surgical mortality rates to less than 3% in high-volume medical centers. However, the 
incidence of postoperative complication remains high, which ranges from 30% to 50% and the 
pancreatic fistula rate ranges from 5% to 40%.  
Since the ISGPF classification was declared in 2005, it has been widely accepted. The rate of clinically 
relevant postoperative pancreatic fistula (CR-POPF) continued to persist at approximately 15%.The CR-
POPF is one of the most important life-threatening complications that could lead to intra-abdominal 
abscess, hemorrhage, and sepsis. The exocrine output from the pancreatic remnant was now widely 
implicated as the initial cause of fistula. The underlying process is the continuous leakage of caustic 
proteases and lipolytic enzymes, with significant local consequences (abscess, pancreatic fistula, acute 
pancreatitis, pseudoaneurysm) and systemic sequelae (sepsis, shock, pulmonary insufficiency). So the 
clinically significant pancreatic fistula symptoms were caused by enzyme leakage and inflammation 
including bacterial and non- bacterial inflammation. The enzyme may be the initial promoting factor but 
the inflammation facilitated by enzyme was another important factor in the development of pancreatic 
fistula. The higher body weight, undilated main pancreatic duct and soft gland were widely accepted as 
the risk factors of CR-POPF and all these patient factor couldn’t be changed by the surgeons. So the 
feasible and easy way to decrease the CR-POPF is to improve the enteric reconstruction technique of 
pancreatic stump.  
There 
were 
different 
techniques 
of 
enteric 
reconstruction, 
including: 
invagination 
pancreaticojejunostomy, binding pancreaticojejunostomy, duct-to-mucosa pancreaticojejunostomy, 
Roux-en-Y pancreaticojejunostomy, and pancreaticogastrostomy and each technique had its advantages 
and disadvantages. Several anastomotic surgical techniques have been developed to reduce the 
incidence of pancreatic fistula in recent decades, including, Peng’s binding method, Bulgmart Method. 
Large prospective studies and meta-analyses show no significant differences in postoperative 
complications and mortality among these reconstruction methods. Invagination pancreaticojejunostomy 
and duct-to-mucosa pancreaticojejunostomy are the most popular technique of pancreaticojejunostomy. 
However invagination pancreaticojejunostomy is difficult to perform in the situation of larger pancreatic 
remnant and soft gland. Duct-to-mucosa pancreaticojejunostomy is difficult to perform in the situation 
of thinner pancreatic duct and the uncompleted drainage of the pancreatic remnant is also considered 
to be the important reason of CR-POPF. 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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Theoretically, the incision of "Shark Mouth" might facilitate the pancreaticojejunostomy especially for 
the large pancreatic remnant; the feature of anastomosis might reduce the tension of 
pancreaticojejunostomy, which is important for the healing of anastomosis and might reduce the risk of 
POPF in the soft pancreas; the characters of anastomosis permits total drainage of pancreatic remnant, 
which is crucial in the situation of thinner pancreatic ducts. The purpose of this study is to evaluate the 
new anastomosis called "Shark Mouth Modified Pancreaticojejunostomy", especially the morbidity of 
POPF. 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
The main risks for study patients are the occurrence of postoperative pancreatic fistula and other 
complications after the performance of the shark mouth modified pancreaticojejunostomy. The rest 
potential risks are related with the rest clinically established standard surgical procedures.  
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
The main potential benefit for study patients is reducing the occurrence of postoperative pancreatic 
fistula as well as other complications after the performance of the shark mouth modified 
pancreaticojejunostomy. All rest surgical procedures carried out are clinically established standard 
procedures. 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
 
The newly established digestive reconstruction technique named shark mouth modified 
pancreaticojejunostomy has theoretical advantages including easier performed lower tension and less 
complication.  Thus we performed the current clinical trial to investigate the clinical efficacy of the shark 
mouth modified pancreaticojejunostomy.  
 
3 
OBJECTIVES AND ENDPOINTS 
  
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To evaluate the new procedure 
shark mouth modified 
pancreaticojejunostomy (SMMP) 
 Postoperative pancreatic fistula 
(POPF) occurrence rate. 
 
Postoperative 
pancreatic fistula 
(POPF) is one of the 
most frequent and 
ominous complications 
after PD, which is 
somehow related with 
the anastomosis 
technique 
Secondary 
 
 
To popularize SMMP.  
Anastomosis time 
Morbidities besides the POPF 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Postoperative hospital stay 
 
 
 
 
 
 
 
 
 
 
 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
This study is a prospective observational study evaluating the clinical efficacy of shark mouth modified 
pancreaticojejunostomy. The study will enroll a total of 120 participants who need to undergo the 
pancreaticoduodenectomy and will last for 2 years. The patients will underwent the shark mouth 
modified pancreaticojejunostomy procedure and be followed up. The primary endpoint of the study is 
the incidence of postoperative pancreatic fistula. The secondary endpoint is the postoperative hospital 
stay, morbidity, and the anastomosis time of the pancreaticojejunostomy procedure.  
 
4.2 
END OF STUDY DEFINITION 
 
The end of the study is defined as completion of the last visit at 3 months after the operation.  
 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
Patients who meet the following criteria will be included in the study: 
  1.Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy 
2.Operation-tolerated 
3.Informed consent 
 
5.2 
EXCLUSION CRITERIA 
  
An individual who meets any of the following criteria will be excluded from participation in this study: 
  1. History of abdominal operation 
  2. Pancreaticoduodenectomy is given up during operation 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
8 
  3. Patients require to exit from the study anytime 
  4. Pregnancy 
 
5.3 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in the clinical trial but are not 
subsequently assigned to the study intervention. A minimal set of screen failure information is required 
to ensure transparent reporting of screen failure participants, to meet the Consolidated Standards of 
Reporting Trials (CONSORT) publishing requirements and to respond to queries from regulatory 
authorities. Minimal information includes demography, screen failure details, eligibility criteria, and any 
serious adverse event (SAE).  
 
 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION 
 
Posters will be displayed in the outpatient and inpatient departments of Peking University Third Hospital 
in order to enroll the potential participants. The brief introduction of the clinical trial and the contact 
information will be printed on the posters.  
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
The SMMP will be performed according to the standard procedure. The remnant of jejunum is closed by 
continuous suture. The transverse incision is made on the posterior wall of the jejunum (5 centimeters 
distal to remnant）, which starts at 0.2 centimeter to the mesenteric border and should never exceed 
the anti-mesenteric border . In case of large pancreas remnant, a longitudinal jejunum incision will be 
done at anterior part of anastomosis.The posterior part of anastomosis is two layers of intermittent 
suture, including seromuscular suture layer and full thickness suture layer. The anterior part of 
anastomosis is a single layer full thickness suture. At last, the seromuscular layer of the proximal 
jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of anastomosis.  
 
6.2 
STUDY INTERVENTION COMPLIANCE 
 
The compliance will be assessed by the records of the follow up information.  
 
6.3 
CONCOMITANT THERAPY 
 
For this protocol, a prescription medication is defined as a medication that can be prescribed only by a 
properly authorized/licensed clinician. Medications to be reported in the Case Report Form (CRF) are 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
9 
concomitant prescription medications, over-the-counter medications and supplements. The use of 
somatostatin, somatostatin analogs, antibiotics and acid inhibitors should be recorded.  
 
 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
  
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
 
Discontinuation from SMMP does not mean discontinuation from the study, and remaining study 
procedures should be completed as indicated by the study protocol.  If a clinically significant finding is 
identified (including, but not limited to changes from baseline) after enrollment, the investigator or 
qualified designee will determine if any change in participant management is needed. Any new clinically 
relevant finding will be reported as an adverse event (AE).The data to be collected at the time of study 
intervention discontinuation . 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
 
Patients can withdraw from the trial at their own request or at the request of their legal representative 
at any time. Patients may be removed if, in the investigator’s opinion, continuation of the trail could be 
detrimental to the patient’s well-being or if a PD is not performed due to technical unresectability, 
metastatic disease, or other reasons. Every withdrawal will be recorded in the clinical report forms (CRFs) 
and in the patient’s medical case records. All examinations scheduled for the final trial day will be 
performed on all patients and documented. All data will be analyzed according to the intention-to-treat 
(ITT) principle.  
 
7.3 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for scheduled visits on 3 
weeks and 3 weeks after the operation is unable to be contacted by the study site staff.  
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
•The site will attempt to contact the participant and reschedule the missed visit and counsel the 
participant on the importance of maintaining the assigned visit schedule and ascertain if the participant 
wishes to and/or should continue in the study. 
•Before a participant is deemed lost to follow-up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and, if necessary, a certified letter 
to the participant’s last known mailing address or local equivalent methods). These contact attempts 
should be documented in the participant’s medical record or study file.  
•Should the participant continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up.  
 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
  
8.1 
EFFICACY ASSESSMENTS  

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
10 
All outcome variables will be evaluated according to internationally accepted standards and scoring 
systems if available, i.e. the consensus definitions for pancreatic fistula of the International Study Group 
of Pancreatic Surgery (ISGPS).  
 
The efficacy of the shark mouth modified pancreaticojejunostomy will be comprehensively assessed by 
the symptoms (e.g. febrile, abdominal pain, exsufflation), signs (e.g. tenderness, rebound tenderness, 
increased amount of drainage fluids), laboratory examinations of the blood (e.g. amylase), drainage 
fluids (e.g. amylase), and imaging examinations (e.g., abdominal CT scanning).  
 
 
8.2 
SAFETY AND OTHER ASSESSMENTS 
 
The safety of the shark mouth modified pancreaticojejunostomy will be comprehensively assessed by 
the following： 
 
the vital signs (e.g. temperature, heart rate, respiratory rate and blood pressure), 
 
laboratory examinations of the blood (e.g. blood routine test, liver function). 
 
 
   
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
  
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
Adverse event means any untoward medical occurrence associated with the shark mouth modified 
pancreaticojejunostomy, whether or not considered intervention-related.  
 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the participant and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition.   
 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
  
8.3.3.1 SEVERITY OF EVENT 
  
For adverse events (AEs) not included in the protocol defined grading system, the following guidelines 
will be used to describe severity.  

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
11 
 
•Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
•Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. 
Moderate events may cause some interference with functioning. 
•Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or 
other treatment. Severe events are usually potentially life-threatening or incapacitating.  Of note, the 
term “severe” does not necessarily equate to “serious”.  
 
 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
  
All adverse events (AEs) must have their relationship to study intervention assessed by the clinician who 
examines and evaluates the participant based on temporal relationship and his/her clinical judgment. 
The degree of certainty about causality will be graded using the categories below. In a clinical trial, the 
study product must always be suspect.  
 
•Related – The AE is known to occur with the study intervention, there is a reasonable possibility that 
the study intervention caused the AE, or there is a temporal relationship between the study intervention 
and event. Reasonable possibility means that there is evidence to suggest a causal relationship between 
the study intervention and the AE. 
•Not Related – There is not a reasonable possibility that the administration of the study intervention 
caused the event, there is no temporal relationship between the study intervention and event onset, or 
an alternate etiology has been established. 
 
 
8.3.3.3 EXPECTEDNESS  
 
The study monitor from the Ethics Committee of Peking University Third Hospital will be responsible for 
determining whether an adverse event (AE) is expected or unexpected.  An AE will be considered 
unexpected if the nature, severity, or frequency of the event is not consistent with the risk information 
previously described for the study intervention. 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
  
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (CRF). Information to be collected includes event description, time of 
onset, clinician’s assessment of severity, relationship to study product (assessed only by those with the 
training and authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
12 
occurring while on study must be documented appropriately regardless of relationship. All AEs will be 
followed to adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE.  
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The study monitor from the Ethics Committee of Peking University Third Hospital will record all 
reportable events with start dates occurring any time after informed consent is obtained until 7 (for 
non-serious AEs) or 30 days (for SAEs) after the last day of study participation.  At each study visit, the 
investigator will inquire about the occurrence of AE/SAEs since the last visit.  Events will be followed for 
outcome information until resolution or stabilization.  
 
 
8.3.5 ADVERSE EVENT REPORTING  
 
In case of AEs, the AEs should be reported in 24 hours to the study main sponsors and ethics committee 
by telephone or fax. And the AEs records should be submitted in 24 hours.  
 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
 
The study investigator shall complete an Unanticipated Adverse Device Effect Form and submit to the 
study sponsor and to the reviewing Institutional Review Board (IRB) as soon as possible, but in no event 
later than 10 working days after the investigator first learns of the effect.  The study sponsor is 
responsible for conducting an evaluation of an unanticipated adverse device effect and shall report the 
results of such evaluation to the local medical administration ministry  and to all reviewing IRBs and 
participating investigators within 10 working days after the sponsor first receives notice of the effect. 
Thereafter, the sponsor shall submit such additional reports concerning the effect as the local medical 
administration ministry requests.  
 
 
8.3.7 REPORTING OF PREGNANCY  
 
Pregnant patients will be excluded from the current trial.  
 
 
8.4 
UNANTICIPATED PROBLEMS 
 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
 
  

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The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
participants or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
•Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the approved research protocol and informed 
consent document; and (b) the characteristics of the participant population being studied; 
•Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research). 
•Suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized.  
 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
 
The investigator will report unanticipated problems (UPs) to the Ethics Committee of Peking University 
Third Hospital. The UP report will include the following information: 
 
•Protocol identifying information: Protocol title and number, PI’s name, and the IRB project number; 
•A detailed description of the event, incident, experience, or outcome;  
•An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
•A description of any changes to the protocol or other corrective actions that have been taken or are 
proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
•UPs that are serious adverse events (SAEs) will be reported to Ethics Committee of Peking University 
Third Hospital within 3 days of the investigator becoming aware of the event.  
•Any other UP will be reported to the IRB and to Ethics Committee of Peking University Third Hospital 
within 10 of the investigator becoming aware of the problem.  
 
 
9 
STATISTICAL CONSIDERATIONS  
  
9.1 
STATISTICAL HYPOTHESES 
 
Primary Efficacy Endpoint(s):  
The occurrence of POPF.  
 
 
Secondary Efficacy Endpoint(s): 
 
Anastomosis time 
Morbidities besides the POPF 
Postoperative hospital stay 
 

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9.2 
SAMPLE SIZE DETERMINATION 
  
Sample size calculation is based on the primary endpoint: POPF rate. An assumed absolute risk of 10% 
difference in POPF occurrence is the appropriate basis for the calculation assuming 10% POPF in the 
SMMP technique group and 20% in the previous published data (Harnoss JC, Ulrich AB, Harnoss JM et al 
(2014) Use and results of consensus definitions in pancreatic surgery: a systematic review. Surgery 
155:47–57). This calculation yields a total of 108 patients in the SMMP technique group, which assures a 
power of 80 % at a two-sided level of significance of 5 % (NCSS and PASS 11 (NCSS Statistical Software, 
Kaysville, UT, USA)). Assuming an expected withdrawal rate of 10 % during the trial, 12 additional 
patients will be included; therefore, the total sample size required is n = 120 patients.  
 
 
9.3 
POPULATIONS FOR ANALYSES 
 
•Modified Intention-to-Treat Analysis Dataset (e.g., participants who underwent the shark mouth 
modified pancreaticojejunostomy and have some particular amount of follow-up outcome data) 
•Per-Protocol Analysis Dataset: defines a subset of the participants in the full analysis (ITT) set who 
complied with the protocol sufficiently to ensure that these data would be likely to represent the effects 
of study intervention according to the underlying scientific model (e.g., participants who took at least 80% 
of study intervention for 80% of the days within the maintenance period)  
•Safety Analysis Dataset: defines the subset of participants for whom safety analyses will be conducted 
(e.g., participants who took at least one dose of study intervention) 
 
 
9.4 
STATISTICAL ANALYSES 
  
9.4.1 GENERAL APPROACH 
  
•For descriptive statistics. Categorical data will be presented in numbers with percentages. Continuous 
data will be presented in means with standard deviations or medians with ranges.  
•A two-tailed P<0.05 was considered statistically significant.   
 
 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
  
POPF was defined and graded according to criteria proposed by the International Study Group on 
Pancreatic Fistula (ISGPF) as amylase-rich fluid (more than threefold greater than the upper limit of 
serum amylase level) of any measurable volume on or after postoperative day 3. POPF was subclassified 
into grade A (abnormal laboratory parameters without change in clinical management), grade B 
(abnormal laboratory parameters with non-invasive change in clinical management) and grade C 
(abnormal laboratory parameters requiring invasive treatment). In the present clinical trial, we will only 
calculate the incidence of POPF of the study participants.  
 
Participants who underwent the shark mouth modified pancreaticojejunostomy and have some 
particular amount of follow-up outcome data (Modified Intention-to-Treat Analysis Dataset) will be 
analyzed.  

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9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
  
Anastomosis time is defined as time from beginning to end of shark mouth modified 
pancreaticojejunostomy, which is measured by the timer. Morbidities besides the POPF is classified 
according to the Clavien-Dindo definition as grade I to grade V. Postoperative hospital stay is defined as 
the length of hospital stay after the operation. As an observational study, no inferial analysis will be 
performed.  
 
Participants who underwent the shark mouth modified pancreaticojejunostomy and have some 
particular amount of follow-up outcome data (Modified Intention-to-Treat Analysis Dataset) will be 
analyzed.  
 
9.4.4 SAFETY ANALYSES 
  
The present study is evaluating the safety endpoint, all of the factors are included in Section 9.4.2-
Section 9.4.3. Each AE will be counted once only for a given participant. Severity, frequency, and 
relationship of AEs to study intervention will be presented by System Organ Class (SOC). Start date, stop 
date, severity, relationship, expectedness, outcome, and duration about each AE will be reported.  
Serious treatment-emergent AEs should be presented either in a table or a listing.  
 
 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
  
The baseline demographics information includes age, gender, and race. The baseline laboratory 
measurements include the blood routine test, serum liver function, serum renal function, serum 
amylase, serum tumor marker and coagulation function test.  
 
 
9.4.6 SUB-GROUP ANALYSES 
 
The subgroup analyses will be analyzed based on age, sex, the texture of the pancreas, diameter of the 
main pancreatic duct and the primary diseases.  
 
9.4.7 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
 
Individual participant data will be listed by measure and time point. 
 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
  
 

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10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
  
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to administering study 
intervention.  The following consent materials are submitted with this protocol.  
 
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
  
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be - Ethics 
Committee of Peking University Third Hospital approved and the participant will be asked to read and 
review the document. The investigator will explain the research study to the participant and answer any 
questions that may arise. A verbal explanation will be provided in terms suited to the participant’s 
comprehension of the purposes, procedures, and potential risks of the study and of their rights as 
research participants.  Participants will have the opportunity to carefully review the written consent 
form and ask questions prior to signing. The participants should have the opportunity to discuss the 
study with their family or surrogates or think about it prior to agreeing to participate. The participant 
will sign the informed consent document prior to any procedures being done specifically for the study. 
Participants must be informed that participation is voluntary and that they may withdraw from the 
study at any time, without prejudice. A copy of the informed consent document will be given to the 
participants for their records. The informed consent process will be conducted and documented in the 
source document (including the date), and the form signed, before the participant undergoes any study-
specific procedures. The rights and welfare of the participants will be protected by emphasizing to them 
that the quality of their medical care will not be adversely affected if they decline to participate in this 
study.  
 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
  
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to study participants, investigator, and regulatory 
authorities>.  If the study is prematurely terminated or suspended, the Principal Investigator (PI) will 
promptly inform study participants, the Ethics Committee of Peking University Third Hospital, and 
sponsor and will provide the reason(s) for the termination or suspension.  Study participants will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
•Determination of unexpected, significant, or unacceptable risk to participants 
•Demonstration of efficacy that would warrant stopping    
•Insufficient compliance to protocol requirements 
•Data that are not sufficiently complete and/or evaluable 
•Determination that the primary endpoint has been met 
•Determination of futility 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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Study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the sponsor, IRB and/or the local medical administration ministry.  
 
 
10.1.3 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their staff, 
and the sponsor(s) and their interventions. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to participants. Therefore, the 
study protocol, documentation, data, and all other information generated will be held in strict 
confidence. No information concerning the study or the data will be released to any unauthorized third 
party without prior written approval of the sponsor.  
 
All research activities will be conducted in as private a setting as possible. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the Institutional 
Review Board (IRB), regulatory agencies supplying study product may inspect all documents and records 
required to be maintained by the investigator, including but not limited to, medical records (office, clinic, 
or hospital) and pharmacy records for the participants in this study. The clinical study site will permit 
access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at the Ethics Committee of Peking University Third Hospital. This will not 
include the participant’s contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The study data entry and study 
management systems used by clinical sites and by Ethics Committee of Peking University Third Hospital 
research staff will be secured and password protected. At the end of the study, all study databases will 
be de-identified and archived at the Ethics Committee of Peking University Third Hospital.  
 
 
 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
  
Data collected for this study will be analyzed and stored at the Ethics Committee of Peking University 
Third Hospital. After the study is completed, the de-identified, archived data will be transmitted to and 
stored at the Ethics Committee of Peking University Third Hospital, for use by other researchers 
including those outside of the study. Permission to transmit data to the Ethics Committee of Peking 
University Third Hospital will be included in the informed consent.  
 
With the participant’s approval and as approved by local Institutional Review Boards (IRBs), de-
identified biological samples will be stored at the Ethics Committee of Peking University Third Hospital 
with the same goal as the sharing of data with the Ethics Committee of Peking University Third Hospital. 
These samples could be used to research the causes of <specify condition(s)>, its complications and 

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other conditions for which individuals with < specify condition(s)> are at increased risk, and to improve 
treatment. The Ethics Committee of Peking University Third Hospital will also be provided with a code-
link that will allow linking the biological specimens with the phenotypic data from each participant, 
maintaining the blinding of the identity of the participant. 
 
During the conduct of the study, an individual participant can choose to withdraw consent to have 
biological specimens stored for future research. However, withdrawal of consent with regard to 
biosample storage may not be possible after the study is completed.  
 
When the study is completed, access to study data and/or samples will be provided through the Ethics 
Committee of Peking University Third Hospital. 
 
 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
  
Principal Investigator 
Medical Monitor 
Dianrong Xiu , Dr. The director of 
the Department of General 
Surgery  
Xue Hong, Dr. 
Department of General Surgery, 
Peking University Third Hospital 
Peking University Third Hospital 
Medical Science Research Ethics 
Committee 
49 North Garden Rd., Haidian 
District Beijing 100191,P.R.China 
49 North Garden Rd., Haidian 
District Beijing 
100191,P.R.China 
+8615611908135 
+86-010-82265883 
Email: 
xiudianrong7320@163.com 
Email: bysyec@163.com 
 
 
 
 
 
10.1.6 SAFETY OVERSIGHT 
 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of 
individuals with the appropriate expertise. Members of the DSMB should be independent from the 
study conduct and free of conflict of interest, or measures should be in place to minimize perceived 
conflict of interest.  The DSMB will meet at least semiannually to assess safety and efficacy data on each 
arm of the study. The DMSB will operate under the rules of an approved charter that will be written and 
reviewed at the organizational meeting of the DSMB. At this time, each data element that the DSMB 
needs to assess will be clearly defined. The DSMB will provide its input to the study sponsor/National 
Institutes of Health staff.  
 
 
10.1.7 CLINICAL MONITORING 
 

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Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of 
the trial is in compliance with the currently approved protocol/amendment(s), with International 
Conference on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory 
requirement(s).  
 
•The monitor from the Ethics Committee of Peking University Third Hospital will conduct the monitoring 
every 2 weeks throughout the study. Random review of the study data will be performed.  
•Independent audits will be conducted by  the Ethics Committee of Peking University Third Hospital to 
ensure monitoring practices are performed consistently across all participating sites. 
 
 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
 
Our institution will perform internal quality management of study conduct, data and biological specimen 
collection, documentation and completion.  
 
 
10.1.9 DATA HANDLING AND RECORD KEEPING  
  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the electronic case report 
form (eCRF) derived from source documents should be consistent with the data recorded on the source 
documents.  
 
Clinical data (including adverse events (AEs), concomitant medications, and expected adverse reactions 
data) and clinical laboratory data will be entered into the record system provided by the Ethics 
Committee of Peking University Third Hospital. The data system includes password protection and 
internal quality checks, such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate. Clinical data will be entered directly from the source documents. 
 
 
 
10.1.9.2 STUDY RECORDS RETENTION  
  
Study documents should be retained for a minimum of 2 years after the completion of the primary 
endpoint. These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It is 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained.  
 
 
10.1.10 
PROTOCOL DEVIATIONS  
  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 5 working days of 
the scheduled protocol-required activity.  All deviations must be addressed in study source documents, 
reported to Ethics Committee of Peking University Third Hospital and sponsor.  Protocol deviations must 
be sent to the reviewing Institutional Review Board (IRB) per their policies. The site investigator is 
responsible for knowing and adhering to the reviewing IRB requirements. Further details about the 
handling of protocol deviations will be included in the MOP.  
 
 
10.1.11 
PUBLICATION AND DATA SHARING POLICY 
  
This study will be conducted in accordance with the following publication and data sharing policies and 
regulations: 
 
 This study will comply with  the Clinical Trials Registration and Results Information Submission rule. As 
such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be 
submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-
reviewed journals.  Data from this study may be requested from other researchers 5 years after the 
completion of the primary endpoint by contacting Ethics Committee of Peking University Third Hospital.  
 
 
10.1.12 
CONFLICT OF INTEREST POLICY 
  
 This is a clinical research sponsored by the primary investigator, and there was no conflicts to disclose. 
 
 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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10.2 ABBREVIATIONS 
The list below includes abbreviations utilized in this template.   
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT 
Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
CR-POPF 
clinically relevant postoperative pancreatic fistula 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act  
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS 
Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PD 
Pancreaticoduodenectomy 
PI 
Principal Investigator 
POPF 
postoperative pancreatic fistula 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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SMMP 
Shark Mouth Modified Pancreaticojejunostomy 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
 

 Shark Mouth Modified Pancreaticojejunostomy                                                                                             v.<20171101> 
 
 
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10.3 PROTOCOL AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Chen Y J, Lai EC, Lau WY, et al. Enteric reconstruction of pancreatic stump following 
pancreaticoduodenectomy: a review of the literature. Int J Surg. 2014;12(7):706-11. 
 2.Bassi C, Dervenis C, Butturini G, et al. International Study Group onPancreatic Fistula Definition. 
Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 
Jul;138(1):8-13. 
3.Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) 
definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-
591..  
4. Søreide K, Labori KJ. Risk factors and preventive strategies for post-operative pancreatic fistula after 
pancreatic surgery: a comprehensive review. Scand J Gastroenterol. 2016 Oct;51(10):1147-54. 
5.McMillan MT, Soi S, Asbun HJ, et al. Risk-adjusted outcomes of clinically relevant pancreatic fistula 
following pancreatoduodenectomy: a model for performance evaluation. Ann Surg. 2016 
Aug;264(2):344-52. 
6. McMillan MT, Vollmer CMJr, AsbunHJ, et al. The characterization and prediction of ISGPF grade c 
fistulas following pancreatoduodenectomy. J Gastrointest Surg. 2016 Feb;20(2):262-76.. 
7.Mcmillan MT, Malleo G, Bassi C, et al. Defining the practice of pancreatoduodenectomy around the 
world. HPB (Oxford). 2015 Dec;17(12):1145-54. 
8.Grobmyer SR, Kooby D, Blumgart LH, et al. Novel pancreaticojejunostomy with a low rate of 
anastomotic failure-related complications. J Am Coll Surg. 2010 Jan;210(1):54-9.  
9.Peng SY, Wang JW, Lau WY, et al. Conventional versus binding pancreaticojejunostomy after 
pancreaticoduodenectomy: a prospective randomized trial. Ann Surg. 2007 May;245(5):692-8. 
 10.Buc 
E, 
Flamein 
R, 
Golffier 
C, 
et 
al. 
Peng’s 
binding 
pancreaticojejunostomy 
after 
pancreaticoduodenectomy: a French prospective study. J Gastrointest Surg. 2010 Apr;14(4):705-10  
11. Maggiori L, Sauvanet A, Nagarajan G, et al. Binding versus conventional pancreaticojejunostomy 
after pancreaticoduodenectomy: a case-matched study. J Gastrointest Surg. 2010 Sep;14(9):1395-400.