SOCCER: Study Of forCeps Cannulation During ERcp
Phase: NA
Conditions: Post-ERCP Acute Pancreatitis
Sponsor: Dartmouth-Hitchcock Medical Center

Project Title: SOCCER: Study Of forCeps Cannulation during ERcp 
 
NCT Number: NCT05336630 
Study Protocol, Updated June 8, 2022 
 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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D-HH IRB OVERSIGHT: 
One of the following must be true in order to submit to the D-HH IRB. Please check all that 
apply: 
 
☒ The Principal Investigator is employed by D-H 
☒ The study will utilize any D-H data or specimens 
☒ The study will enroll D-H patients or recruit from D-H sites 
☒ The study will utilize any D-H resources, e.g. study procedures will occur at  
     D-H locations and/or use of D-H equipment or shared resources 
 
PROTOCOL TITLE: 
SOCCER: Study Of forCeps Cannulation during ERcp 
PRINCIPAL INVESTIGATOR: 
Name: Timothy B. Gardner MD MS 
Department: Gastroenterology and Hepatology 
Telephone Number: 603-650-5261 
Email Address: timothy.b.gardner@hitchcock.org 
VERSION NUMBER/DATE: 
Version 2, June 8, 2022 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
0 
February 4, 
2022 
Original 
 
1 
June 8, 2022 
Added ampullary mass to exclusion criteria 
no 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives ................................................................................................................ 5 
3.0 
Background .............................................................................................................. 5 
4.0 
Study Endpoints ....................................................................................................... 6 
5.0 
Study Intervention/Investigational Agent ................................................................ 6 
6.0 
Procedures Involved................................................................................................. 6 
7.0 
Data and Specimen Banking .................................................................................. 10 
8.0 
Sharing of Results with Subjects ........................................................................... 10 
9.0 
Study Timelines ..................................................................................................... 10 
10.0 Inclusion and Exclusion Criteria ............................................................................ 10 
11.0 Vulnerable Populations .......................................................................................... 12 
12.0 Local Number of Subjects ..................................................................................... 12 
13.0 Recruitment Methods ............................................................................................. 13 
14.0 Withdrawal of Subjects .......................................................................................... 14 
15.0 Risks to Subjects .................................................................................................... 15 
16.0 Potential Benefits to Subjects ................................................................................ 15 
17.0 Data Management and Confidentiality .................................................................. 15 
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 16 
19.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 16 
20.0 Compensation for Research-Related Injury ........................................................... 16 
21.0 Economic Burden to Subjects ................................................................................ 16 
22.0 Consent Process ..................................................................................................... 16 
23.0 Process to Document Consent in Writing .............................................................. 17 
24.0 Setting .................................................................................................................... 17 
25.0 Resources Available............................................................................................... 17 
26.0 Multi-Site Research ............................................................................................... 17 
27.0 
References………………………………………………………………………..17 
 
 
 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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1.0 
Study Summary 
 
Study Title 
SOCCER: Study Of forCeps Cannulation during 
ERcp 
Study Design 
Randomized controlled trial 
Primary Objective 
To determine whether a forceps assisted cannulation leads to 
less difficult cannulation during ERCPs based on a standard 
definition of difficult cannulation 
Secondary 
Objective(s) 
To determine whether the risk of PEP is reduced by forceps 
assisted cannulation 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Eligible patients who have consented will either be 
randomized to cannulation with forceps or cannulation with 
no forceps 
IND/IDE #  
N/A 
Study Population 
Patients undergoing ERCP who have a native papilla 
Sample Size 
152 
Study Duration for 
individual 
participants 
Time of procedure and telephone call one week post-
procedure 
Study Specific 
Abbreviations/ 
Definitions  
AE: adverse event 
 
AP: acute pancreatitis 
 
CBD: common bile duct 
 
DH: Dartmouth-Hitchcock 
 
DHMC: Dartmouth-Hitchcock Medical Center 
 
Difficult cannulation: any cannulation that results in any of 
the following: 5 or more minutes, 5 or more cannulation 
attempts, or 2 or more unintentional pancreatic wire passages 
 
ERCP: endoscopic retrograde cholangiopancreatography 
 
FDA: Food and Drug Administration  
 
GCP: good clinical practice  
 
IRB: institutional review board  
 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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MoP: manual of procedures  
 
OSH: outside hospital 
 
PD: pancreatic duct  
 
PEP: post-ERCP pancreatitis 
 
PI: principal Investigator 
 
RCT: randomized controlled trial  
 
SAE: severe adverse 
 
SOCCER: study of forceps cannulation during ERCP  
 
SOD: Sphincter of Oddi dysfunction 
 
 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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2.0 
Objectives 
• 
The objective of our study is to determine whether a forceps assisted 
cannulation leads to less difficult cannulation during ERCP. Because 
difficult cannulation is associated with increased risk of PEP, our study 
investigates whether the forceps assisted cannulation also reduces the 
incidence of PEP as a secondary outcome. 
• 
We hypothesize that a forceps assisted cannulation will significantly reduce 
the difficulty of cannulation.   
3.0 
Background 
 
Endoscopic retrograde cholangiopancreatography (ERCP), an invasive procedure that combines 
endoscopy and x-ray to treat issues with the bile and pancreatic ducts, carries a two to ten percent 
risk of causing post-ERCP pancreatitis (PEP) [1].  Because acute pancreatitis is a devastating 
inflammatory condition that leads to extensive morbidity and mortality, efforts to reduce the risk 
of PEP in patients undergoing ERCP would enhance patient outcomes and would decrease the 
economic burden in treating PEP nationwide [2-4].  
 
A difficult cannulation has been identified as one of the high risk factors for developing PEP [5]. 
A study performed by Scandinavian Association for Digestive Endoscopy (SADE) determined 
that cannulations with five or more attempts, a duration of five minutes or longer, or two or more 
unintended pancreatic duct (PD) wire passages significantly increased one’s risk for PEP [6]. 
Thus, SADE defined a difficult cannulation as any cannulation with at least one of the following 
conditions: five or more attempts, five or more minutes, or two or more unintended PD wire 
passages [6]. This classification of a difficult cannulation has been adopted and standardized by 
the European Society of Gastrointestinal Endoscopy [7]. Because no current guidelines defining 
a difficult cannulation exist from the American College of Gastroenterology or American 
Gastroenterological Association, the ESGE guidelines as gathered from the SADE study are the 
worldwide standardized definition of difficult cannulation.  
 
Difficult cannulations have been reported to occur at a frequency of 42 percent for all ERCP 
exams [8]. The morphology and accessibility of the papilla influence the level of difficulty. 
Some studies have indicated that different macroscopic appearances of the papilla result in 
varying cannulation difficulty levels. Based on a study gauging intraobersever and interobserver 
agreement to the macroscopic appearance of different papillae, papillae are categorized as: Type 
1, normal appearing; Type 2, small; Type 3, protruding or pendulous; and Type 4, ridged or 
creased [9]. Haraldsson et al. found that Type 2 and Type 3 papillae were more difficult to 
cannulate [8]. Regardless of papilla type, the involvement of a trainee (a GI fellow) resulted in 
more difficult cannulations [8]. In addition, the presence of redundant tissue, such as 
periampullary diverticula4which occurs in up to 20 percent of patients undergoing ERCP4
results in more challenging cannulations [10]. The use of a forceps to assist in the cannulation is 
a demonstrated effective technique for cannulating papillae that are difficult to access [10-12]. 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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The forceps clears the redundant tissue to enable access to the papilla, as well as stabilizes the 
ampullary position to permit an easier cannulation [10]. Currently, no randomized controlled 
trials that detail to what extent a forceps facilitates cannulation exist. Thus, our study aims to 
determine whether a forceps assisted cannulation reduces the incidence of difficult cannulations 
and consequently PEP. 
 
4.0 
Study Endpoints 
• 
The primary outcome is difficult cannulation after randomization. A 
difficult cannulation will be defined as any cannulation that results in any of 
the following: 5 or more minutes, 5 or more cannulation attempts, or 2 or 
more unintentional pancreatic wire passages. 
• 
The secondary outcome is PEP. Acute pancreatitis according to the Atlanta 
guidelines, is at least two of the following: abdominal pain consistent with 
pancreatitis, lipase or amylase greater than 3 times the upper limit of 
normal, radiographic evidence of pancreatitis on cross sectional imaging 
[13].  
5.0 
Study Intervention/Investigational Agent 
• 
Description: The study intervention is the use of a forceps during the 
cannulation. This trial will use one type of forceps called SpyBite forceps. 
Eligible patients who have consented will either be randomized to forceps 
assisted cannulation or no forceps used during cannulation.  
• 
SpyBite forceps is an FDA approved instrument for usage during endoscopy 
and during ERCP. The physician performing the procedure will not be 
blinded. Thus, that doctor will ensure the patient gets the treatment to which 
the patient was randomized and will ensure proper usage of the forceps. The 
forceps is an FDA approved instrument and does not put the patient at any 
higher risk for any AE. Please note that for the explicit purpose of the study 
the forceps will be used to grab tissue and not take biopsies. The forceps 
may still be used to take biopsies if the physician believes it is indicated. 
The trial will run in accordance with federal regulations and IRB 
determinacy.  
6.0 
Procedures Involved 
• 
Study Design 
• This investigation is a randomized controlled trial. Eligible patients 
who have consented will be randomized to either ERCP with 
forceps assisted cannulation or ERCP with no forceps.  
•  
Study sites 

 
 
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• Dartmouth-Hitchcock Medical Center in Lebanon, New 
Hampshire will be the only site where the study takes place. There 
are no satellite sites.  
•  
Recruitment 
• SOCCER plans to enroll 152 patients over 2 years.  
• All patients undergoing ERCP at DHMC endoscopy will be 
approached and consented for this study. Medical records will be 
reviewed to see if they meet inclusion/exclusion criteria. Patients 
will be consented day of the procedure. We will enter a request for 
HIPAA Authorization Waiver because access to a patient’s chart 
will be required to determine inclusion/exclusion criteria. Please 
find the waiver request in the recruitment section.  
• 
 Procedures 
• All patients at DHMC endoscopy who meet inclusion/exclusion 
criteria will be approached and consented for this study. Consent 
will be performed in the endoscopy pre-op area. During the 
standard of care ERCP, the patients will be randomized 
intraoperatively to either cannulation with forceps and cannulation 
with no forceps. Written informed consent will be reviewed and 
signed before any study related procedures are performed. 
• Please note that the primary outcome refers to a difficult 
cannulation AFTER randomization when the secondary inclusion 
criteria has been met. For example, if the secondary inclusion 
criteria met is difficult cannulation, then the primary outcome 
would be if from that point forward there were a difficult 
cannulation. As such, a total cannulation time of 10 minutes would 
enable the patient to be eligible (the first 5 minutes means the 
cannulation is difficult) and would mean the subject met the 
primary outcome (the second 5 minutes means cannulation after 
randomization is difficult). However, a total cannulation time of 8 
minutes means the patient is eligible for the study (first 5 minutes 
means the cannulation is difficult) but did not meet the primary 
outcome (after randomization, the cannulation was not difficult 
because it was only 3 minutes). In a sense, the <difficult 
cannulation clock= is reset after randomization. If the secondary 
inclusion criteria met instead is papilla location or type, then the 
patient is randomized immediately before the cannulation and the 
difficult cannulation clock starts then. Measurement of difficult 
cannulation starts immediately after randomization upon the 
doctor’s first cannulation attempt following randomization.  

 
 
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• Chart review will be performed to determine patient’s past medical 
history as it relates to the study4for example, to determine a 
history of AP or PEP. ERCP will be performed by those who are 
board certified gastroenterologists. Trainees can be involved so 
long as they are under supervision of a board certified 
gastroenterologist who is on faculty at DHMC. The level of 
involvement in the procedure and level of proficiency of the 
trainee will be documented and stored in the database.  
• Randomization procedure 3 Randomization will occur in block 
format.  Randomization assignments will be placed in sealed 
manila envelopes that will be opened at the time of randomization.  
Manila envelopes will be kept with the study coordinator. 
• Randomization will occur when the subject has met necessary 
inclusion criteria and no exclusion criteria, which will not be 
known until the doctors are in the procedure. Randomization will 
thus take place intraprocedurally.  
• After consent, data will be collected before, during, and after the 
procedure. The primary outcome will be measured during the 
procedure, whereas the secondary outcome will be determined 
during the 5 day follow up call. The study coordinator, GI fellow, 
or attending physician will call the patient 5 days (+/- 2 days) post-
procedure to determine whether the patient developed PEP. 
Though it is preferred to contact the patient, other methods (chart 
review, emergency contact, OSH records) are acceptable for 
determining the secondary outcome. Patients will be unblinded to 
their treatment on the follow-up call.  
• Data will be stored in a database on Excel. This database will be 
password protected behind a Dartmouth-Hitchcock firewall and 
only authorized personnel on the research team will have access to 
the study materials including the database.  
• 
The site PI will sign off on the end of study of each subject to ensure quality 
and authenticity of the data.   
 

 
 
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PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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7.0 
Data and Specimen Banking  
• 
Data is kept in a database on a DH server behind the firewall and password 
protected. Access to the database will be limited to the research team. Data 
will be kept for 5 years post publication.  
8.0 
Sharing of Results with Subjects 
• 
Subjects will be unblinded to their treatment on the follow up call.  
9.0 
Study Timelines 
• 
A subject will be in the study for a week.   
• 
We plan to enroll 152 patients over the course of 2 years. Our estimated date 
to complete the study is 2025.  
10.0 Inclusion and Exclusion Criteria 
 
Patient must be able to provide informed consent. If patient provides informed consent and meets 
the following criteria, the patient can participate in the study.  
 
PRIMARY INCLUSION CRITERIA:  If the response to any of the questions below is <NO,= 
the patient is NOT ELIGIBLE to participate in the study. 
 
Patient consented? 
�䃈 YES 
�䃈 NO 
ERCP done on native papilla 
�䃈 YES 
�䃈 NO 
SECONDARY INCLUSION CRITERIA: If the response to any of the questions below is 
<YES,= the patient IS eligible 
 
Papilla in a diverticulum 
�䃈 YES 
�䃈 NO 
Papilla on rim of a diverticulum 
�䃈 YES 
�䃈 NO 
Difficult cannulation (5 attempts, 5 minutes, or 2 unintended PD wire passages) 
�䃈 YES 
�䃈 NO 
Redundant tissue overlaying papilla 
�䃈 YES 
�䃈 NO 
Type 2, 3, or 4 papilla (see figure below for reference) 
�䃈 YES 
�䃈 NO 
 
 
 
EXCLUSION CRITERIA:  If the response to any of the questions below is <YES,= the 
patient is NOT ELIGIBLE to participate in the study.  
 
Prior ampullectomy 
�䃈 YES 
�䃈 NO 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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Ampullary mass 
�䃈 YES 
�䃈 NO 
Known pregnancy, positive test, breastfeeding 
�䃈 YES 
�䃈 NO 
Clinical contraindication to ERCP 
�䃈 YES 
�䃈 NO 
Metal allergy 
�䃈 YES 
�䃈 NO 
Prior sphincterotomy 
�䃈 YES 
�䃈 NO 
Inability to follow protocol 
�䃈 YES 
�䃈 NO 
<18 years old 
�䃈 YES 
�䃈 NO 
Enrolled in another ERCP 
�䃈 YES 
�䃈 NO 
Biliary/PD stent in place 
�䃈 YES 
�䃈 NO 
 
 
 
 
 
 
 
Figure from Haraldsson E, Lundell L, Swahn F, et al. 
Endoscopic classification of the papilla of Vater. Results 
of an inter- and intraobserver agreement study. United 
European Gastroenterol J. 2017;5(4):504-510. 
doi:10.1177/2050640616674837 

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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11.0 Vulnerable Populations 
• 
The study will not involve any patients in vulnerable populations. 
12.0 Local Number of Subjects 
• 
152 patients will be enrolled. 
• 
Our power calculation was performed using Sample Size Calculator from 
ClinCalc LLC [14]. Based on our experience, we believe that a forceps 

 
 
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assisted cannulation results in a 50 percent decrease in the incidence of a 
difficult cannulation. Data has demonstrated that a difficult cannulation has 
an incidence of 42 percent [8]. Thus, by setting the incidence of difficult 
cannulation in our two groups at 42 percent and 21 percent, we determined 
our sample size is 152 patients with 76 in each treatment group. Alpha value 
is p<0.05 and power is set to 80 percent. Data analysis will involve chi 
square tests for categorical variables and student’s t-tests for continuous 
variables. Analysis will be conducted using Microsoft Excel (Microsoft 
Corporation, Redmond, WA). 
13.0 Recruitment Methods  
• 
All patients undergoing ERCP at DHMC will be approached for the study. 
A HIPAA Authorization waiver will be required so that patients can be 
screened in the electronic health records prior to procedure for 
inclusion/exclusion criteria.  
• 
GI Research has the resources needed to conduct this study and the support 
of the GI providers to help identify and recruit subjects. 
• 
The GI Research team is made up of four coordinators, a research nurse, the 
research operations manager, and any physicians involved in the study who 
are fully dedicated to running clinical research. 
• 
The GI Research study team has locked offices and access to all technology 
needed to successfully run a study. 
• 
No payment or advertising will be done.  
The GI Research Team also request a Waiver of the HIPAA Authorization for recruitment.  GI 
Research Team members, who are workforce members of D-H, will use eDH (medical records) 
to identify potential research participants for this study. 
 
The GI Research Team agrees that: 
- 
The use or disclosure is sought solely to review PHI as necessary to prepare the research 
- 
No PHI will be removed from the covered entity during the review 
- 
The PHI that the researcher seeks to use or access is necessary for the research purpose 
 
The GI Research Team further agrees that: 
 
1. The use or disclosure of protected health information involves no more than a minimal 
risk to the privacy of individuals, based on, at least, the presence of the following 
elements: 
 
a. an adequate plan to protect the identifiers from improper use and disclosure 3  

 
 
PROTOCOL TITLE: SOCCER: Study Of forCeps Cannulation during ERcp 
 
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Identifiers used in recruitment will not be shared with anyone outside of the GI 
Research Team. 
b. an adequate plan to destroy the identifiers at the earliest opportunity consistent 
with conduct of the research, unless there is a health or research justification for 
retaining the identifiers or such retention is otherwise required by law;  
Identifiers that do not lead to recruitment will be destroyed at the end of the study.  
Identifiers that lead to recruitment will be linked to the Case Report Forms via a 
key that will be kept by the GI Research Team and only shared in accordance 
with the terms set forth in the Informed Consent document. 
c. adequate written assurances that the protected health information will not be 
reused or disclosed to any other person or entity, except as required by law, for 
authorized oversight of the research project, or for other research for which the 
use or disclosure of protected health information would be permitted by this 
subpart;  
Protected Health Information (PHI) will only be used or disclosed as outlined in 
the protocol for this research project. 
 
2. The research could not practicably be conducted without the waiver or alteration;  
The GI Research Team cannot practicably identify and recruit subjects without this 
waiver. 
 
3. The research could not practicably be conducted without access to and use of the 
protected health information.  
The GI Research Team cannot practicably identify and recruit subjects without 
access to their PHI for screening purposes. 
14.0 Withdrawal of Subjects 
• 
If cannulation reaches 30 minutes without success, and the attending 
physician believes it to be in the patient’s best interest to switch treatment 
groups, then the attending may switch treatments. These patients will be 
followed in the study with intention to treat analysis.  
• 
If cannulation is determined to be medically futile by the PI or a Sub-I after 
5 minutes of attempting to cannulate, and the attending physician believes 
that it is in best interest of the patient to switch from <no forceps= to 
<forceps= then the attending may switch treatment groups. These patients 
will be followed in the study under their original treatment group per 
intention to treat analysis and be categorized as difficult cannulation, as 
defined by 5 minutes of unsuccessful cannulation.  
• 
If during the procedure, the attending notices that a patient who had 
consented to the study meets exclusion criteria or no inclusion criteria, then 
the subject will be withdrawn from the study and be informed following the 
procedure.  

 
 
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• 
If patients decide not to continue in the study after initially giving consent, 
they must submit their request in writing to the site PI. These patients will 
not be followed in order to respect their autonomy. However, data will be 
collected and analyzed up until the point at which they revoke their consent 
for participation in the study.  
• 
If a patient exits the study due to an SAE, the patient will be followed still 
with an intention to treat analysis. Data will be collected from chart review, 
OSH records, or emergency contact.  
15.0 Risks to Subjects  
• 
The risk to the subjects is no greater than the standard risks of an ERCP, 
which is the procedure they would already be receiving. Participants will 
sign a separate consent form to give permission for the procedure, as is 
standard of care. The study intervention of the forceps does not put the 
subjects at any greater risk for harm.  
• 
Because the ERCP is standard of care, the cost of the procedure is covered 
by the patient’s insurance and will not result in any additional cost for the 
patient. The cost of forceps will be covered by established DHMC GI 
department research funds (Dartmouth Pancreas Research Fund) in order to 
make sure there is no increased or additional cost for the patient.  A grant to 
the American Society of Gastrointestinal Endoscopy will also be submitted 
in December 2022 to cover the cost of the forceps 3 although a negative 
review from this grant application will not inhibit study completion.  
16.0 Potential Benefits to Subjects  
• 
Though we can make no guarantees, it is our hope that the forceps assisted 
cannulation reduces the difficulty of cannulation in an effort to reduce the 
risk of PEP and to decrease procedure time. We hope to gather information 
that will improve the procedure in the future.  
17.0 Data Management and Confidentiality  
• 
All data is secured in a database on a DH server behind the DH firewall and 
password protected. Access to the database will be limited to the research 
team 
• 
Our power calculation was performed using Sample Size Calculator from 
ClinCalc LLC [14]. Based on our experience, we believe that a forceps 
assisted cannulation results in a 50 percent decrease in the incidence of a 
difficult cannulation. Data has demonstrated that a difficult cannulation has 
an incidence of 42 percent [8]. Thus, by setting the incidence of difficult 
cannulation in our two groups at 42 percent and 21 percent, we determined 
our sample size is 152 patients with 76 in each treatment group. Alpha value 

 
 
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is p<0.05 and power is set to 80 percent. Data analysis will involve chi 
square tests for categorical variables and student’s t-tests for continuous 
variables. Analysis will be conducted using Microsoft Excel (Microsoft 
Corporation, Redmond, WA).  
• 
The PI will sign off on every patient’s end of study to verify the authenticity 
of the data as a quality control measure.  
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects  
• 
We will have no formal data monitoring committee, but the PI will review 
and sign off on every patient’s end of study to verify the authenticity of the 
data as a quality control measure 
19.0 Provisions to Protect the Privacy Interests of Subjects  
• 
Subject Case Report Forms (CRFs) will only include the subject’s study 
number. The research team will have a key linking the subject to his/her 
study number. The key will be housed on a DH server, password protected 
and behind the DH firewall. No PHI will be published or shared.  
20.0 Compensation for Research-Related Injury  
• 
No compensation will be provided. The research does not involve more than 
minimal risk to subjects.  
21.0 Economic Burden to Subjects   
• 
There is no additional cost for the subjects. The ERCP, as a standard of care 
procedure, is covered by their insurance plans and will be billed to the 
subject or his/her insurance. The cost of the forceps will be covered by the 
study to ensure that subjects will not have any additional cost.  
22.0 Consent Process  
• 
Consent will take place in the endoscopy suite at DHMC in Lebanon, New 
Hampshire the day of the patient’s ERCP. Eligible patients will be 
approached to determine interest in participation.  
• 
The study will be following SOP: Informed Consent Process for Research 
(HRP-090).   
Non-English Speaking Subjects  
• 
Non-English speakers will not be included in the study. 
Waiver or Alteration of Consent Process (consent will not be obtained, 
required information will not be disclosed, or the research involves 
deception) 

 
 
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• 
Not applicable because the research does not involve any of the 
elements in bold above.  
Subjects who are not yet adults (infants, children, teenagers) 
• 
The study does not include subjects who are not yet adults. 
Cognitively Impaired Adults 
• 
The study does not include subjects who are cognitively impaired.  
. Adults Unable to Consent NA 
• 
The study does not include subjects who are not able to consent. 
 
23.0 Process to Document Consent in Writing  
• 
We will follow HRP 091(SOP: Written Documentation of Consent).  
24.0 Setting  
• 
Our research will be conducted at DHMC in Lebanon, New Hampshire. 
Study procedures will be conducted in the DHMC Lebanon endoscopy suite.  
25.0 Resources Available 
• 
GI Research has the resources needed to conduct this study and the support 
of the GI providers to help identify and recruit subjects. 
• 
The GI Research team is made up of four coordinators, a research nurse, the 
research operations manager, and any physicians involved in the study who 
are fully dedicated to running clinical research. 
• 
The GI Research study team has locked offices and access to all technology 
needed to successfully run a study. 
 
26.0 Multi-Site Research  
• 
DHMC in Lebanon, New Hampshire is the only site for the research.  
 
27.0 References 
 

 
 
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1. Thaker AM, Mosko JD, Berzin TM. Post-endoscopic retrograde cholangiopancreatography 
pancreatitis. Gastroenterol Rep (Oxf). 2015;3(1):32-40. doi:10.1093/gastro/gou083 
 
2. Neoptolemos JP, Raraty M, Finch M, Sutton R. Acute pancreatitis: the substantial human and 
financial costs. Gut. 1998;42(6):886-891. doi:10.1136/gut.42.6.886 
 
3. Freeman ML, Nelson DB, Sherman S, et al. Complications of endoscopic biliary 
sphincterotomy. N Engl J Med. 1996;335(13):909-918. doi:10.1056/NEJM199609263351301 
 
4. Elmunzer BJ, Serrano J, Chak A, et al. Rectal indomethacin alone versus indomethacin and 
prophylactic pancreatic stent placement for preventing pancreatitis after ERCP: study protocol 
for a randomized controlled trial [published correction appears in Trials. 2020 Jun 
3;21(1):471]. Trials. 2016;17(1):120. Published 2016 Mar 3. doi:10.1186/s13063-016-1251-2 
 
5. Freeman ML, Guda NM. Prevention of post-ERCP pancreatitis: a comprehensive 
review. Gastrointest Endosc. 2004;59(7):845-864. doi:10.1016/s0016-5107(04)00353-0 
 
6. Halttunen J, Meisner S, Aabakken L, et al. Difficult cannulation as defined by a prospective 
study of the Scandinavian Association for Digestive Endoscopy (SADE) in 907 ERCPs. Scand J 
Gastroenterol. 2014;49(6):752-758. doi:10.3109/00365521.2014.894120 
 
7. Testoni PA, Mariani A, Aabakken L, et al. Papillary cannulation and sphincterotomy 
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