Comparison Between an Angled-tip and Straight-tip Guidewire in Biliary Cannulation: a Prospective, Randomized Trial
Phase: NA
Conditions: Bile Duct Diseases
Sponsor: Neev Mehta

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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Title Page:  
Comparison between an angled-tip and straight-tip guidewire 
in biliary cannulation: a prospective, randomized trial 
 
Principle Investigator:  
Ann Marie Joyce MD 
Program Director, Advanced Endoscopy Fellowship 
Director of Advanced Endoscopy  
Clinical Associate Professor of Medicine, Tufts University School of Medicine  
Division of Gastroenterology and Hepatology 
Lahey Hospital and Medical Center  
 
Sub-Investigators: 
Samson Ferm MD 
Advanced Endoscopy Fellow  
Division of Gastroenterology and Hepatology 
Lahey Hospital and Medical Center  
 
 
 
 
 
 
 
 
 
 

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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Table of Contents 
 
 
 
Research Objectives/Specific Aims/Outcomes Measures 
 
Background Information/Significance/Scientific Rationale 
 
Participant Selection/Eligibility  
 
Subject Enrollment  
 
Study Design/Procedures 
 
Study Calendar/Schematic/Schedule 
 
Potential Risks/Discomforts 
 
Potential Benefits 
 
Statistical Analysis  
 
Data Management 
 
Data and Safety Monitoring and Quality Assurance  
 
References  
 
 
 
 
 
 
 
 

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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Research Objectives/Specific Aims/Outcomes Measures  
Wire-guided cannulation of the common bile duct is a standard technique utilized during 
Endoscopic Retrograde Cholangio-Pancreatography (ERCP) to ensure safe and effective 
access to the common bile duct via the ampulla of Vater. Due to the anatomy of the ampulla, 
and the orientation of the biliary orifice, a guidewire with an angled tip may allow easier and 
safer access to the common bile duct without inadvertent manipulation of the pancreatic duct. 
We aim to assess the technical and clinical outcomes between an angled-tip guidewire (GW) 
compared to a straight-tip guidewire in wire-guided cannulation of the common bile duct. We 
hypothesize that an angled-tip GW is associated with increased rate of successful cannulation, 
decreased procedure time and decreased rate of post-ERCP pancreatitis in wire-guided biliary 
cannulation during ERCP.  
Primary Research Question:  
Is the use of an angled-tip guidewire associated with increased rate of successful 
cannulation of the common bile duct in ERCP? 
Secondary Research Questions:  
Is the use of an angled-tip guidewire associated with decreased procedure 
duration? 
Is the use of an angled-tip guidewire associated with reduced rates of post-ERCP 
pancreatitis? 
Is cannulation more successful using an angled-tip wire in a particular type of 
papilla?  
 
Background Information / Significance / Scientific Rationale  
Endoscopic Retrograde Cholangio-pancreatography is a commonly performed procedure for 
diagnostic and therapeutic purposes in the setting of biliary tract pathology. During ERCP, bile 
duct access is performed with use of a catheter (sphincterotome) that is passed beyond the 
papilla into the bile duct. The utilization of a guidewire, over which the catheter is passed, to 
ensure selective common bile duct cannulation (as opposed to pancreatic duct cannulation) is 
associated with improved overall cannulation rates and lower risks of post-ERCP pancreatitis, 
and this practice has become standard.1 A variety of guidewires are available to the 
endoscopist. The guidewires vary in size, stiffness and design of the tip of the wire, which may 
be straight, angled, J-shaped or tapered.  Angled-tip guidewires were shown to result in 
decreased procedure duration, with a similar rate of cannulation and complications as compared 
to a straight tipped wire in a randomized-controlled trial including 239 patients.2 Aside from this 
RCT, there is a paucity of literature that compares angled-tip and straight tip-guidewires in  
 

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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biliary cannulation. In theory, an angled-tip guidewire may result in better technical performance 
including rate of successful cannulation, duration of procedure, and incidence of post-ERCP 
pancreatitis because of the anatomy of the ampulla of Vater and the oblique trajectory of the 
biliary orifice.  Our goal is to compare the rate of successful cannulation, duration of procedure 
and incidence of post-ERCP pancreatitis between an angled-tip guidewire and straight-tip 
guidewire. This study will aid in the performance of ERCP and in the proper selection of devices 
to ensure safe and effective biliary cannulation. Additionally, this research may reduce 
healthcare expenditure by identifying an alternative device that may reduce the duration of the 
ERCP procedure. 
 
Participant Selection / Eligibility  
Patients undergoing ERCP with native papilla and pancreatico-biliary disease who are 
candidates for ERCP with biliary cannulation are eligible for enrollment.  Subjects must meet all 
inclusion criteria in order to be eligible to participate in the study.  
Inclusion Criteria:  
Patients undergoing ERCP for cholangiography, bile or tissue sampling from the 
gallbladder or bile duct, or for treatment of biliary diseases (removal of common bile duct 
stones, biliary stent placement) 
Exclusion Criteria: 
Patients who are less than 18 years old  
Pregnant patients  
Patients who have undergone previous bile duct cannulation or sphincterotomy  
Patients who have undergone prior endoscopic balloon dilation or needle-knife 
fistulotomy 
Patients who have undergone gastric surgery (Billroth gastrectomy II, Roux-en-Y gastric 
bypass) 
Patients with acute pancreatitis 
 
Patients who refuse endoscopic intervention  
Patients with ampullary tumor, duodenal stenosis, or pre-operatively proven 
pancreaticobiliary malunion 
 
Subjects will be recruited based upon their need to undergo ERCP for biliary diagnosis or 
therapy as determined by the principal investigator or sub-investigators.  This determination will 
be made based upon the clinical requirement of endoscopic biliary cannulation. Subjects will be 
either inpatients or outpatients who require ERCP and bile duct cannulation. The overall sample 
size will be approximately 248 patients. Pregnant women will not be recruited for participation in 
this study as ERCP in certain pregnancies may be harmful to the fetus especially during the first 
trimester.  Additionally, minors (age less than 18 years old) and prisoners will not be recruited or 
enrolled in the study, as these are vulnerable populations who may have a compromised ability 
to make an informed decision about participation.  
 
 

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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Subject Enrollment  
 
All patients enrolled in the study will be required to sign an informed consent form to participate 
in the study as well as for the resultant data to be collected and used for analysis and eventual 
publication.  Consent will be obtained via a paper consent form on the day of procedure by the 
research team. A copy of the consent form will be made and given to the subject and the 
original copy will be stored in a secure file on site. All known risks, benefits and alternative 
therapies will be explained to the patient by either the PI or sub-investigators prior to signing the 
consent form.  The patient will be randomized to a study arm in a 1:1 fashion by a computer-
generated random number list via the REDCap Electronic Data capture application after 
informed consent has been obtained and just prior to the start of the procedure by either the PI 
or the sub-investigators.  
 
Study Design and Procedures 
This is a prospective, randomized, unblinded trial performed at Lahey Hospital and Medical 
Center.  All procedures will be performed by experienced advanced endoscopists with over 
2000 career ERCP’s and 350 ERCP’s performed per year, (or by the advanced endoscopy 
fellow under supervision of the attending gastroenterologist). Enrolled patients will be randomly 
assigned by a computer-generated number list to 2 groups (group 1, angled-tip GW; group 2, 
straight-tip GW). All procedures will be performed using standard duodenoscope or Exalt 
duodenoscope (JF-260V; Olympus Medical Systems Corp, Tokyo, Japan). For the procedure, 
patients will receive either general anesthesia or monitored anesthesia care as clinically 
indicated. Medications will be administered by a licensed anesthesiologist or CRNA. All 
procedures will be performed via short-wire technique using a 0.025-inch, 260cm-long angled 
guidewire with 5-cm hydrophilic tip (Jagwire Revolution, Boston Scientific, Natick, MA) or a 
0.025-inch, 260-cm long straight guidewire with a 5-cm hydrophilic tip. (Jagwire, Boston 
Scientific, Natick, MA) For cannulation, attending gastroenterologists will be allowed 5 minutes 
to cannulate (from first contact of ampulla) or 5 passes inadvertently into the pancreatic duct 
(whichever occurs first).  If the procedure is performed by gastroenterology fellow, the fellow will 
be allowed 5 minutes from first contact with the ampulla or 5 passes into the pancreatic duct 
(whichever occurs first). If the pancreatic duct is cannulated, double guide-wire technique will be 
performed with the same wire (0.025-inch guidewire) for an additional 5 minutes. If cannulation 
remains unsuccessful, needle-knife technique will be performed with pancreatic duct stenting 
performed. This protocol is similar to Vihervaara et al.2   Post-procedurally, patients will be 
monitored for post-ERCP pancreatitis with either inpatient follow-up or via a phone call if 
procedure performed as outpatient. Post-ERCP pancreatitis will be defined as new or worsened 
abdominal pain combined with >3 times the normal value of lipase more than 24 hours after 
ERCP and requirement of hospital admission or prolongation of a planned admission. Routine 
blood work will be collected upon admission and during hospitalization as clinically warranted.  
Data will be collected using the REDCap data collection application and will be securely stored 
on LHMC secured servers.  

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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Standard of Care: Procedure in both treatment groups is considered standard of care as they 
use FDA approved devices. Here at Lahey, The endoscopists use both guidewires. The 
guidewire is selected based on physician preference. While they typically start with a straight-tip 
wire, they would also use angled-tip guidewire if the straight tip guidewire does not achieve 
cannulation of the bile duct. Data shows that both guidewires are safe to use with similar rates 
of successful cannulation and adverse events. 
 
Study Calendar / Schematic / Schedule  
The main study-required visit will be the day of the planned procedure (ERCP). On this visit, the 
pre-procedural process will include a discussion with the patient regarding the risks and benefits 
of the procedure as well as a description of the study and consent for participation in the study. 
Pre-procedure data will be collected and entered into the data capture tool. The data collected 
will include patient demographics and indication for procedure.  Randomization will then be 
performed immediately prior to the start of the planned procedure and the randomization 
assignment will be entered into the data capture tool. Data will then be collected immediately 
after the procedure and will include procedure duration, successful cannulation determination, 
pancreatic duct cannulation determination, types of guidewires used during procedure, fellows 
involvement in procedure and complications of procedure.  On post-procedure day one to post 
procedure day five, post-procedural data will be collected by either inpatient assessment or by a 
telephone call to the subject if the procedure was performed on an outpatient basis by either the 
PI or sub-investigators. If there is a concern for possible post-ERCP pancreatitis, a lipase level 
will be checked on an inpatient or outpatient basis. There will be no other planned study-
required visits after post-procedure day five.  Subjects will be removed from enrollment if they 
choose to withdraw from the study.  
 
Potential Risks and Discomforts  
The main risk of participation in this study is breach of confidentiality that pertains to data 
collection. This risk will be addressed in the “data management” section. There will be no 
additional risk to subjects based upon randomization to either arm of the study as data has 
shown that either wire (angled-tip vs straight-tip) are equally safe and confer no higher risk of 
adverse events.2  
The risk associated with ERCP includes bleeding, infection, perforation or post-ERCP 
pancreatitis.3 The risk of bleeding is 1.3%.3 The risk of infection (ascending cholangitis) is less 
than 1%.3 The risk of perforation is 0.1 to 0.6%.3 The risk of post-ERCP pancreatitis is 3.5%.3 
These risks can range from mild in severity to severe and life threatening. These risks will be 
minimized by virtue of the procedures being performed by or under the supervision of 
experienced endoscopists with over 2000 procedures performed and by following evidence-

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
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based practice in the pre, intra, and post-procedural care of the subjects.  Adverse events will 
be reported to the appropriate Lahey Hospital and Medical Center committee and to the IRB.  
 
Potential Benefits  
Aside from the benefit from the procedure itself for therapeutic and diagnostic purposes, 
patients will not directly benefit from the research being performed. We hope that our findings 
will have benefits for future patients undergoing the ERCP procedure.  
 
Statistical Analysis  
The sample size needed to achieve statistical significance for the primary outcome is 248 (207 
*1.2) after adding 20% screen failure rate. The power of the study to detect if there is a true 
difference will be 0.80. It will take approximately six months to reach the target accrual. The 
variables that need to be collected include demographics, co-morbidities, laboratory values, 
date of procedure, diagnosis, outcome of procedure (success of cannulation), duration of 
procedure, post-procedure complications (including post-ERCP pancreatitis) and fellow 
involvement in procedure. The outcome variables include rate of successful cannulation, and 
incidence of post-ERCP pancreatitis. Predictor variables include co-morbidities, indication for 
procedure and fellow involvement in procedure. Potential confounding variables include differing 
anatomy of papilla amongst subjects, underlying etiology of biliary obstruction (which may be 
different from suspected pre-procedure diagnosis) or unforeseen biliary pathology which alters 
procedure. The study endpoints will be achieved by showing a statistically significant difference 
in the rate of successful cannulation using an angled-wire as compared to a straight wire as 
defined as a p-value of less than 0.05. The proportion of procedures that are successful in the 
two treatment arms will be compared using chi squared analysis. Similarly, the rate of 
development of pancreatitis will be compared using chi squared analysis. The total duration of 
the procedure will be compared using a T-Test for comparing mean if the data are normally 
distributed or a Wilcoxon rank sum test if not normally distributed. 
 
Data Management  
All data will be collected using the REDCap Data Collection application and will be stored 
electronically on this platform. Only the PI and sub-investigators will have access to the 
password encrypted REDCap database. There will be no transmission of the acquired data off 
site. The data set will not include patient names or other identifiers.  Information for this study 
will be available as required to the FDA, Massachusetts Department of Health, and LHMC IRB. 
Names of subjects will not be mentioned in publications or case reports. 
 

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
Page 8 of 9 
 
Data and Safety Monitoring and Quality Assurance  
The principal investigator will be responsible for data and safety monitoring and quality 
assurance. This will be conducted by weekly team meetings to review the consent process; 
collection of data and post-procedural follow up of study subjects. Additionally, there will be a bi-
weekly review of the accuracy and completeness of the database and of the storing of 
completed consent forms in the appropriate secured file on the LHMC campus. The sub-
investigators will report directly to the PI any possible breach in protocol and will be responsible 
for regularly monitoring for quality assurance of the study protocol.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title: Comparison between angled-tip and straight-tip guidewire in biliary 
cannulation: A prospective, randomized trial 
Protocol Version Number: Version 1.0 Protocol Date: 08/29/2022 
 
Page 9 of 9 
 
References: 
1 Cennamo V, Fuccio L, Zagari RM, Eusebi LH, Ceroni L, Laterza L, Fabbri C, Bazzoli F. Can a 
wire-guided cannulation technique increase bile duct cannulation rate and prevent post-ERCP 
pancreatitis?: A meta-analysis of randomized controlled trials. Am J 
Gastroenterol. 2009;104:2343–2350.  
2 Vihervaara H, Grönroos JM, Koivisto M, Gullichsen R, Salminen P. Angled- or straight-tipped 
hydrophilic guidewire in biliary cannulation: a prospective, randomized, controlled trial. Surg 
Endosc. 2013 Apr;27(4):1281-6. doi: 10.1007/s00464-012-2596-6. Epub 2012 Dec 19. PMID: 
23250671. 
3 ASGE Standards of Practice Committee, Anderson MA, Fisher L, Jain R, Evans JA, 
Appalaneni V, Ben-Menachem T, Cash BD, Decker GA, Early DS, Fanelli RD, Fisher DA, 
Fukami N, Hwang JH, Ikenberry SO, Jue TL, Khan KM, Krinsky ML, Malpas PM, Maple JT, 
Sharaf RN, Shergill AK, Dominitz JA. Complications of ERCP. Gastrointest Endosc. 2012 
Mar;75(3):467-73. doi: 10.1016/j.gie.2011.07.010. PMID: 22341094.