Prospective Evaluation of Residual Bile Duct Stone Detection by Peroral Cholangioscopy That Is Missed With Conventional ERCP and Cholangiogram
Conditions: Gall Stones
Sponsor: Northwell Health

 
 
FWA #00002505 
Human Research Protection Program 
3333 New Hyde Park Road, Suite 317 
New Hyde Park, NY 11042 
Phone: 516-321-2100 
 
 
 
 
To: 
Divyesh Sejpal MD 
300 COMMUNITY DRIVE 
MANHASSET, NY  11030 
From: Hallie Kassan, MS, CIP 
Director, Human Research Protection Program 
Date: 
December 06, 2016 
 
RE: 
IRB #: 
HS15-0674  
 
Protocol Title: 
PROSPECTIVE EVALUATION OF RESIDUAL BILE DUCT STONE 
DETECTION BY PERORAL CHOLANGIOSCOPY THAT IS MISSED 
WITH CONVENTIONAL ERCP 
 
Approval Date: 
December 06, 2016 
 
Expiration Date: 
December 05, 2017 
 
Dear Dr. Sejpal: 
This is to advise you that the Progress Report submission received December 06, 2016 for the above 
referenced study was reviewed by the Institutional Review Board on December 06, 2016 and the 
following determination was made:  
Expedited Approval for the following:  
1. Protocol ( Version date 11/14/16) 
2. Informed Consent ( Version date 12/6/16)  Re-Consent is not required 
3. The appropriate documentation has been submitted for the removal of Peter Stein. 
4. The appropriate documentation has been submitted to add Molly Stewart; she is not approved to 
obtain informed consent. 
5. The following investigators are authorized to participate on this study and obtain informed 
consent: Divyesh Sejpal, Benley George, Larry Miller, Arvind Trindade, Calvin Lee, Sumant 
Inamdar, and Anil Vegesna.  
 
This study qualifies for expedited review per:  45 CFR 46.110(9) – Continuing review of research, not 
conducted under an IND application or IDE where categories 2-8 don’t apply, but the IRB has 
determined and documented at a convened meeting that the research involves no greater than minimal 
risk and no additional risks have been identified. 
 
All conditions of approval previously established by the IRB for this research project continue to 
apply. The Institutional Review Board - will be notified of this action. 
 

NOTE:  This approval is subject to recall if at any time the conditions and requirements as 
specified in the IRB Policies and Procedures are not followed: 
1. Using only IRB-approved consent forms, questionnaires, letters, advertisements, etc. in your 
research.  
2. Submitting any modifications made to the study for IRB review prior to the initiation of 
changes except when necessary, to eliminate apparent, immediate hazards to the subject.  
3. Reporting unanticipated problems involving risk to subjects or others. 
4. Renewing the study at the interval set by the Institutional Review Board.  You should submit 
a progress report to the Institutional Review Board at least two months prior to expiration of 
the study.  Failure to receive notification that it is time to renew does not relieve you of your 
responsibility to provide the IRB with the Progress Report in time for the request to be 
processed and approved prior to your expiration date.  
5. Prior to implementation, any changes made to studies utilizing TAP must have COPP, 
as well as IRB approval.  
  
IMPORTANT REMINDER:  The International Committee of Medical Journal Editors 
(ICMJE) requires registration of clinical research studies meeting specific guidelines prior to 
publication.  Please see ICMJE requirements for registration of clinical trials at 
http://www.icmje.org/. Our organization account is in the name of Northwell Health. To register 
your trial:  http://prsinfo.clinicaltrials.gov/. You must register your trial PRIOR TO 
ENROLLING SUBJECTS.  
 

Version Date: 11/14/2016 
 
Page 1 of 21 
 
RESEARCH PROTOCOL 
 
 
Protocol Title: 
 PROSPECTIVE EVALUATION OF RESIDUAL BILE DUCT 
STONE DETECTION BY PERORAL CHOLANGIOSCOPY 
THAT IS MISSED WITH CONVENTIONAL ERCP 
Principal Investigator: 
Divyesh Sejpal, MD 
Primary Contact Name: 
George Benley 
Primary Contact Phone: 
516-562-3337 
Primary Contact E-mail: 
Bgeorge7@nshs.edu 
Date Revised: 
11/14/2016 
IRB Number: 
HS15-0674 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
 You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
 Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
Trial Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use 
the Protocol Plus.   
o Your study is a registry or repository for data and/or samples, In this case, use 
Protocol Template – Registry Studies.  .   
 If a section of this protocol is not applicable, please indicate such. 
 Do not delete any of the text contained within this document. 
 Please make sure to keep an electronic copy of this document.  You will need to use it, if 
you make modifications in the future.   
 Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial 
submission, this row will be left blank.   
 Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 Continue to next page to begin entering information about this study  
 
 
 
 

Version Date: 11/14/2016 
 
Page 2 of 21 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes   if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
 The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
 It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
 This section should be ½ page 
 
 
Gallstone disease affects over 20 million Americans.1   Among patients 
with gallbladder disease, the prevalence of choledocholithiasis (stones in the bile 
duct) is estimated to be 10-20% 2, 3 Endoscopic retrograde 
cholangiopancreatography (ERCP) is considered the standard of care for removing 
stones in the bile duct utilizing a variety of conventional methods including biliary 
sphincterotomy, sphincteroplasty, extraction balloon, retrieval basket, and 
mechanical lithotripsy.  After removal of stones from the bile duct, an occlusion 
cholangiogram is usually performed to confirm complete bile duct clearance.  
However, cholangiogram can miss residual stones in 11- 30% of cases  - especially 
in the setting of a dilated bile duct, large stones, severe pneumobilia, juxtapapillary 
diverticulum, primary sclerosing cholangitis, and after lithotripsy (mechanical, 
electrohydraulic, or laser).4-7 The approach to patients with choledocholithiasis 
requires careful attention because missed bile duct stones can cause recurrent 
biliary symptoms, pancreatitis, cholangitis, and has significant cost implication 
with the need for repeat imaging and/or procedures. 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
 Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
 Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
 Describe the importance of the knowledge expected to result 
 

Version Date: 11/14/2016 
 
Page 3 of 21 
Peroral cholangioscopy (POC) provides direct visualization of the bile duct 
during ERCP and its benefits are well documented in numerous published studies.  
POC has been described for therapy of difficult to remove biliary stones utilizing 
electrohydraulic lithotripsy or laser lithotripsy with success rates of >90%.8-10  POC 
has also been used for evaluation of indeterminate filling defects and to assess for 
residual stones missed with cholangiogram.  In a multicenter study evaluating POC 
for a variety of indications, 11% (7/66) of patients had bile duct stones identified 
only by POC that were missed on ERCP.4 In a study of patients with primary 
sclerosing cholangitis, 30% (7/23) of patients were found to have stones with POC 
that were missed with cholangiography.5 Takao et al. assessed residual bile duct 
stones found with POC in comparison to balloon-cholangiography; they found that 
24% (26/108) of patients had residual stones seen with POC that were missed with 
balloon-cholangiography.6 
Although POC has been available for over thirty years, it has not become a 
widespread technique due to the fact that traditional cholangioscopes are fragile, 
cumbersome to use, and usually require two endoscopists to perform the procedure.  
A recent single operator semi-disposable cholangioscope, SpyGlass (Boston 
Scientific, Natick, Massachusetts), has addressed those concerns and has been 
shown in a studies to be a useful tool in visualizing the bile ducts and performing 
therapeutic maneuvers for biliary stones.4,11 
 
 
4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
 A concise statement of the goal(s) of the current study.  
 The rationale for and specific objectives of the study.  
 The goals and the hypothesis to be tested should be stated. 
 
This is Prospective, single center study (One IRB, Two hospitals: North 
Shore University Hospital [NSUH] and Long-Island Jewish Medical Center [LIJ]) 
The primary goal of the study is to assess if POC will enhance the 
diagnostic yield in the detection of residual biliary stones that are missed during 
conventional ERCP.  Residual bile duct stones can especially be seen in the setting 
of bile duct dilation, history of recurrent abnormal liver function tests, and after 
lithotripsy (mechanical, electrohydraulic, or laser). Missed biliary stones can lead 
to recurrent biliary symptoms, pancreatitis, and cholangitis. POC after 
conventional ERCP can be a useful diagnostic tool to confirm complete extraction 
of bile duct stones, and thus lead to decreased morbidity and decreased cost by 
avoiding unnecessary tests and repeat procedures. 
Primary Endpoint: 
The primary end point is to detect the presence of any stones seen during POC 
that were missed during conventional ERCP 

Version Date: 11/14/2016 
 
Page 4 of 21 
Secondary Endpoints: 
a. Identify the change in management after finding stone on POC e.g. balloon 
sweep, stent placement, etc. 
Identify the recurrence of biliary obstructive symptoms and/or imaging suggestive 
of recurrent (missed) stones which will be assessed with phone call at 3 months 
after procedure. 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
 Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
 Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
Every year more than 150 patients undergo ERCP procedure in NSUH and LIJMC. 
Most of these patients will be eligible for participation in this study. 
 
All personnel involved in the study are going to be part of the study and must have 
completed the necessary trainings for participation. All involved personnel will be 
informed of any changes in the protocol either through email or in person by the 
co-coordinator or the PI.  
 
 
6.  RECRUITMENT METHODS 
 Describe the source of potential subjects 
 Describe the methods that will be used to identify potential subjects 
 Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
 If monetary compensation is to be offered, this should be indicated in the protocol 
 
All consecutive patients with suspected or documented bile duct stones who satisfy 
eligibility criteria and who consent for participation in the study will be included in 
the study.  
The source of potential subjects is the endoscopy suites at NSUH and at LIJMC. 
Majority of patients who were scheduled for standard of care ERCP procedure 
already have either documented or suspected presence of bile duct stones. 
There are no advertisements for the recruitment as all the patients approached for 
consent are already scheduled for standard of care procedures.  
There is no monetary compensation for participation in the study. 
 

Version Date: 11/14/2016 
 
Page 5 of 21 
 
7.  ELIGIBILITY CRITERIA 
 Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
 Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 
 Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
Inclusion Criteria 
1. 
Patients above the age of 18. 
2. 
Patient receiving ERCP as standard of care for suspected or documented 
choledocholithiasis as assessed by one or more of the following:  
1. Abnormal imaging on ultrasound, endoscopic ultrasound (EUS), CT 
scan, or MRCP suggestive of choledocholithiasis 
2. Clinical signs and symptoms suggestive of choledocholithiasis such as 
jaundice, abdominal pain, pruritis, pancreatitis, and/or cholangitis 
3. Abnormal liver function tests suggestive of choledocholithiasis (eg: 
serum bilirubin > 1.5 and/or  elevated alkaline phosphatase levels)  
3. 
In addition to one or more of the above inclusion criteria, patient must also 
satisfy one or more of the following: 
1. Mechanical lithotripsy, electrohydraulic lithotripsy, or laser lithotripsy 
performed for therapy of bile duct stones. 
2. Bile duct > 12mm on prior tests (any portion of duct) 
3. History of recurrent abnormal LFTs with negative cholangiogram.  
4. Positive EUS or MRCP for biliary stones with a negative 
cholangiogram  
 
Exclusion criteria 
1. Patients less than 18 years of age. 
2. Patients not undergoing ERCP as their standard of care. 
3. Patients who had the following surgeries - Billroth II surgery, Roux-en-Y 
Gastric bypass surgery, and Whipple’s surgery. 
 
 
 
8.  NUMBER OF SUBJECTS 

Version Date: 11/14/2016 
 
Page 6 of 21 
 Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
 If your study includes different cohorts, include the total number of subjects in each 
cohort. 
 If this is multisite study, include total number of subjects across all sites.   
 
Number of patients: 100 who undergo POC in NSUH and in LIJMC 
 
 
 
 

Version Date: 11/14/2016 
 
Page 7 of 21 
9.  STUDY TIMELINES 
 Describe the duration of an individuals participation in the study 
 Describe the duration anticipated to enroll all study subjects 
 The estimated date of study completion 
 
The duration of the individual participation in the study is 3 months after their 
standard of care procedure for a phone follow-up. 
Proposed duration of study:  1 year (enrollment 9 months + follow-up phone call at 
3 months post-procedure). 
Estimated date of study completion is December 2016. 
 
 
10.  ENDPOINTS 
 Describe the primary and secondary study endpoints 
 Describe any primary or secondary safety endpoints  
 
Primary Endpoint: 
The primary end point is to detect the presence of any stones seen during POC 
that were missed during conventional ERCP 
Secondary Endpoints: 
b. Identify the change in management after finding stone on POC e.g. balloon 
sweep, stent placement, etc. 
c. Identify the recurrence of biliary obstructive symptoms and/or imaging 
suggestive of recurrent (missed) stones which will be assessed with phone 
call at 3 months after procedure. 
 
 
11.  RESEARCH PROCEDURES 
 Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
 Include any screening procedures for eligibility and/or baseline diagnostic tests 
 Include procedures being performed to monitor subjects for safety or minimize risks 
 Include information about drug washout periods 
 If drugs or biologics are being administered provide information on dosing and route 
of administration 
 Clearly indicate which procedures are only being conducted for research purposes. 
 If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
 Describe any source records that will be used to collect data about subjects 
 Indicate the data to be collected, including long term follow-up 

Version Date: 11/14/2016 
 
Page 8 of 21 
 
All consecutive patients with suspected or documented choledocholithiasis 
who satisfy recruitment criteria outlined in Section 4 above and who consent for 
participation in the study will be included in the study.  
Clinically indicated standard of care procedure/s: 
ERCP will be performed with cannulation of the bile duct and 
cholangiogram to identify any biliary stones. If stones are identified, they will be 
removed with conventional methods including sphincterotomy, sphincteroplasty, 
balloon extraction, basket retrieval, and/or lithotripsy.  An occlusion 
cholangiogram will be performed to confirm duct clearance (usually performed by 
inflating the catheter balloon at the proximal common hepatic duct near the hilum 
and then pulling the balloon through the bile duct and into the duodenum. Then, 
based on clinical decision and inclusion criteria, the cholangioscope (Spyglass) will 
be inserted through the channel of the endoscope and into the bile duct.  Any 
residual stones will be documented followed by further treatment as indicated e.g. 
stone extraction, lithotripsy, stent placement, etc.  
All patients with suspected cholechodoliathiasis potentially meeting the 
Inclusion criteria will be enrolled in the study.This is the reason for taking the 
consent before hand when the patient is not sedated. However if on clinical 
judgment during the procedure, the physician decides not to perform the POC then 
the subject will be deemed as screen failure and will not be counted towards the 
final results of the study. 
Research procedures:  
1. Document the number of subjects who did and did not have any missed 
stones as identified by SpyGlass. 
2. Document the number of stones missed if there were any. 
3. Document clinical management after finding a stone.(eg: balloon sweep, 
lithotripsy, stent placement, etc.) 
4. Follow-up contact with the participant ≈3 months after the ERCP 
procedure if he/she is enrolled and had undergone cholangioscopy with 
Spyglass to document any recurrent stones/procedures/interventions. 
5. Medical history will be obtained either directly from the patient or from 
the patient medical records which may also include questions about 
prior problems with medications used for sedation or other unusual 
medication reactions. 
6. De-identified ERCP, endoscopic, EUS and SpyGlass images and/or 
video recordings may be collected for review, analysis, presentations 
and publications. 
 
 

Version Date: 11/14/2016 
 
Page 9 of 21 
 
12.  STATISTICAL ANALYSIS 
 Describe how your data will be used to test the hypotheses.  
 State clearly what variables will be tested and what statistical tests will be used. 
 Include sample size calculations.  
 If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
Statistical Considerations: 
Specific Aims: 
1. To estimate the proportion of subjects with missed stones on conventional 
ERCP. 
2. To identify changes in management after finding a stone on POC. 
Endpoint Variables: 
1. Missed stones: Patients will be considered to have missed stones on 
conventional ERCP, if, after ERCP, one or more stones are seen with POC.  
2. Change in management: any maneuver or combination of maneuvers 
performed after a missed stone (e.g. balloon extraction of stone, lithotripsy 
of stone, stent placement, etc.) 
3. Recurrent stones within 3 months after POC, and documentation of 
cholecystectomy as applicable. 
Statistical Methods: 
1. The proportion of subjects with missed stones will be estimated, along with 
the associated exact 95% binomial confidence interval. 
2. Change in management will be described by calculating frequencies and 
percentages for each maneuver performed.  This analysis will be restricted 
to subjects with missed stones. 
3. The proportion of subjects with recurrent stones will be estimated, along 
with the associated exact 95% binomial confidence interval. 
Sample Size Justification: 
The proposed sample size is based on feasibility and availability of 
resources.  The proposed enrollment period for this study will be one year, and it is 
estimated that approximately 140 subjects meeting the qualification criteria will be 
seen during the enrollment period at the participating sites. It is expected that 
nearly all of these patients will consent to participate. Due to the screen failure rate 
of approximately 30% till date we want to enroll a total of 140 subjects to account 
for the screen failures. 

Version Date: 11/14/2016 
 
Page 10 of 21 
 
Based on literature cited earlier, it is estimated that between 11% and 30% 
of these patients will have stones identified on POC that were missed by 
conventional ECRP. The following table gives the 95% exact binomial confidence 
intervals for the proposed sample size of 100 subjects, if the percent with missed 
stones is 10%, 20% and 30%. (For example, if 20 subjects have missed stones, the 
estimated percent with missed stones is 20% and the associated 95% exact 
binomial confidence interval is 12.7% to 29.2%). 
Total Number of 
Subjects in 
Study 
Number of 
Subjects with 
stone seen on 
POC
Percent of 
Subjects with 
stone seen on 
POC
95% Exact 
Binomial 
Confidence 
Interval 
 
100 
 
10
10.0%
4.9% - 17.6%
20
20.0%
12.7% - 29.2%
30
30.0%
21.2% - 40.0%
 
 
 

Version Date: 11/14/2016 
 
Page 11 of 21 
13.  SPECIMEN BANKING 
 If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
 List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
 Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
 Describe the data and specimens to be sent out or received.  As applicable, describe: 
o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
 Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
The principal investigator will be responsible for the management of the protocol.  
All efforts will be made to ensure patient confidentiality and assurance of HIPAA 
compliance. Immediately after obtaining any images, subjects will be assigned a 
protocol specific unique code that will be used for all further data management. A 
list matching the patient medical record number to the protocol specific unique 
code will be kept in a locked cabinet in office of the PI. The names of the patient 
will not be released to any outside organizations or to persons not involved with the 
study. They will not be revealed in written reports or publications detailing the 
research findings. However the information may be released to regulatory 
authorities such as IRB, FDA etc. 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   

Version Date: 11/14/2016 
 
Page 12 of 21 
 
Part I:  Elements of the Data and Safety Monitoring Plan 
  Indicate who will perform the data and safety monitoring for this study.   
 Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
 List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
 Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
 Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
 Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
 Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 
N/A 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
  When appropriate, attach a description of the DSMB.   
 Provide the number of members and area of professional expertise.   
 Provide confirmation that the members of the board are all independent of the study. 
 
N/A 
 
 
16. WITHDRAWAL OF SUBJECTS 
 Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
 Describe procedures for orderly termination 
 Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
Consented patients will be withdrawn from participation and their data will not be 
used if the standard of care procedures described in the protocol cannot be 
performed for any clinical reason such as inaccessibility of bile duct, early 
termination of procedure due to complications etc. The 3 month follow-up phone 
call will not be made if the standards of care procedures are not completed and data 
not collected.  
 
 
17. RISKS TO SUBJECTS 
 Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 

Version Date: 11/14/2016 
 
Page 13 of 21 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
 Include risks to others , like sexual partners (if appropriate) 
 Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to result.  
 Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
There is no additional health risk for the participants of the study due to their 
participation in the study. However their medically required standards of care 
procedures have risks associated with them. If any of the risks arise due to their 
standard of care procedures they will be documented in the CRF for the purpose of 
data analysis. 
 
 
 

Version Date: 11/14/2016 
 
Page 14 of 21 
 
18. RESEARCH RELATED HARM/INJURY 
 Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
 If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
There is no direct research related harm or injury to the patient. All the procedures 
performed in the study are clinically indicated procedures. The research part is the 
collection of data during those procedures.  
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
 Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
 Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
There is no direct benefit to the patient due to participation in the study.  The 
study increasing the knowledge about residual stones which may help in planning 
and delivery of care for other patients with similar conditions in the future. 
 
 
20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
 Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
 In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
The principal investigator will be responsible for the management of the protocol.  
All efforts will be made to ensure patient confidentiality and assurance of HIPAA 
compliance. Immediately after obtaining any images, subjects will be assigned a 
protocol specific unique code that will be used for all further data management. A 
list matching the patient medical record number to the protocol specific unique 
code will be kept in a locked cabinet in office of the PI. The names of the patient 
will not be released to any outside organizations or to persons not involved with the 
study. They will not be revealed in written reports or publications detailing the 
research findings. However the information may be released to regulatory 
authorities such as IRB, FDA etc.
 

Version Date: 11/14/2016 
 
Page 15 of 21 
 
 
21.  COSTS TO SUBJECTS 
 
 Describe any foreseeable costs that subjects may incur through participation in the 
research 
 Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
There are no additional costs to the patients due to their participation in the 
research study. 
 
 
 

Version Date: 11/14/2016 
 
Page 16 of 21 
22.  PAYMENT TO SUBJECTS  
 
 Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
There is no payment to the participants for their participation in this research study. 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
 Who will be obtaining consent 
 Where consent will be obtained 
 Any waiting period available between informing the prospective participant and 
obtaining consent 
 Steps that will be taken to assure the participants’ understanding 
 Any tools that will be utilized during the consent process 
   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
 Procedures for maintaining informed consent.   
 
Only IRB approved personnel will be obtaining the consent. 
Consent will be obtained in the endoscopy pre procedure waiting/preparation 
room. 
After explaining the research the patients will be given time to go through the 
research and the consenting process and then consent will be taken. 
A copy of the consent form will be given to the patient and another copy will be 
placed in the patient health records. The original signed consent form will be 
retained with the study team. 
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
 How parental permission will be obtained 
 From how many parents will parental permission be obtained 
 Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
 Whether or not assent will be obtained from the child 
 How will assent be documented 
 Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   

Version Date: 11/14/2016 
 
Page 17 of 21 
 
No Children will be enrolled in this study. 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
 The process to determine whether an individual is capable of consent 
 Indicate who will make this assessment 
 The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
 If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
N/A 
 
 
If the study will enroll non-English speaking subjects: 
 Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
 Indicate whether or not consent forms will be translated into a language other 
than English 
 Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
 If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
N/A 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
 Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   

Version Date: 11/14/2016 
 
Page 18 of 21 
 Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
 Explain why it is impracticable to conduct this research if informed consent is 
required   
 If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 
 
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
 Explain how the only record linking the subject to the research would be the 
consent document. 
 Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
 Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
 
 
SUBSECTION 2 
  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
 Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
 Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
 Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
 Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 

Version Date: 11/14/2016 
 
Page 19 of 21 
 Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
 Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 
 
 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
 Describe how data will be collected and used:  
 Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 
 Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 
 
If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
Some of the patients who were scheduled for their standard of care procedures may 
belong to one or more of the above checked categories. We will not be specifically 

Version Date: 11/14/2016 
 
Page 20 of 21 
targeting any specific vulnerable populations for the purpose of research. All 
participants will be approached for consenting if they meet the eligibility criteria. All 
the participants in the study will be given a unique code and none of the PHI will be 
used to individually identify the participants. For all data analysis only the given codes 
will be used. 
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
N/A 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 
1. Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder 
disease in the United States. Gastroenterology 1999; 117:632. 
2. Neuhaus H, Feussner H, Ungeheuer A, et al. Prospective evaluation of the use of endoscopic 
retrograde cholangiography prior to laparoscopic cholecystectomy. Endoscopy 1992;24:745-9. 
 
3. Lacaine F, Corlette M, Bismuth H. Preoperative evaluation of the risk of common bile duct 
stones. Arch Surg 1980;115:1114-6. 
 
4. Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, Haluszka O, 
Petersen BT, Sherman S, Devière J, Meisner S, Stevens PD, Costamagna G, Ponchon T, 
Peetermans JA, Neuhaus H. Single-operator cholangioscopy in patients requiring evaluation of 
bile duct disease or therapy of biliary stones. Gastrointest Endosc. 2011; 74(4):805-14.  
 
5. Awadallah NS, Chen YK, Piraka C, Antillon MR, Shah RJ.  Is there a role for cholangioscopy 
in patients with primary sclerosing cholangitis?  Am J Gastroenterol. 2006; 101(2):284-91. 
 
6. Itoi T, Sofuni A, Itokawa F, Shinohara Y, Moriyasu F, Tsuchida A.  Evaluation of residual 
bile duct stones by peroral cholangioscopy in comparison with balloon-cholangiography.  Dig 
Endosc. 2010; 22:S85-9. 
 
7. Maple JT, Ben-Manachem T, Anderson MA, et al.  The role of endoscopy in the evaluation of 
suspected choledocholithiasis.  Gastrointest Endosc. 2010; 71(1):1-8 
 

Version Date: 11/14/2016 
 
Page 21 of 21 
8. Piraka C, Shah RJ, Awadallah NS, Langer DA, Chen YK. Transpapillary cholangioscopy-
directed lithotripsy in patients with difficult bile duct stones.  Clin Gastroenterol Hepatol 
2007;5:1333-8. 
 
9. Arya N, Nelles SE, Haber GB, Kim YI, Kortan PK.  Electrohydraulic lithotripsy in 111 
patients: a safe and effective therapy for difficult bile duct stones.  Am J Gastroenterol 
2004;99:2330-4 
 
10. Farrell JJ, Bounds BC, Al-Shalabi S, Jacobson BC, Brugge WR, Schapiro RH, Kelsey PB.  
Single-operator duodenoscope-assisted cholangioscopy is an effective alternative in the 
management of choledocholithiasis not removed by conventional methods, including mechanical 
lithotripsy.  Endoscopy 2005;37:542-7  
 
11. Chen YK, Pleskow DK. Spyglass single-operator peroral cholangiopancreatoscopy system 
for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study. Gastrointest 
Endosc 2007; 65:832–841.