Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis

Study Overview
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Brief Summary
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One of the major elements of successful endoscopic retrograde cholangiopancreatography ( ERCP) is the timely and uncomplicated cannulation of the common bile duct (CBD) . Various factors may adversely affect the cannulation procedure of the CBD leading to complications (acute pancreatitis after ERCP, perforation of the duodenum , bleeding ). Endoscopic sphincterotomy is frequently required for interventional procedures (eg stone extraction). During sphincterotomy, incision of the orifice of the papilla will be performed by using a sphincterotome. Complications due to sphincterotomy are known: Bleeding, increased rates of acute pancreatitis, small bowel perforation and scarring with consecutive stenosis of the papilla. As an alternative to sphincterotomy, balloon dilatation using balloon catheters can be performed. As a result, bleeding complications and scarring as late effects might be prevented. Current data is limited in terms of the risk of acute pancreatitis after ERCP when using a balloon catheter. This study aims to evaluate the incidence of acute pancreatitis and other complications after ERCP. Balloon dilatation of the papilla will be prospectively compared with endoscopic sphincterotomy in a randomized multicenter setting.

Official Title
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Endoscopic Sphincterotomy vs. Balloon Dilation for Assessment of Pancreatitis: A Prospective Randomized Multicenter Trial

Conditions
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Pancreatitis

Intervention / Treatment
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* Procedure: endoscopic sphincterotomy
* Procedure: balloon dilatation for 3 minutes
* Procedure: balloon dilatation for 6 minutes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: independent indication for ERCP age ≥ 18 years patient is able to understand informed consent Exclusion Criteria: S/p sphincterotomy pancreatic or CBD-stent in situ pregnant patient known chronic pancreatitis acute pancreatitis prior to intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: endoscopic sphincterotomy<br>performing endoscopic sphincterotomy of papilla of Vater during ERCP Device: standard sphincterotome | Procedure: endoscopic sphincterotomy<br>* sphincterotomy during ERCP<br>|
| Active Comparator: balloon dilatation for 3 minutes<br>Balloon dilatation of papilla of Vater for 3 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10mm size) | Procedure: balloon dilatation for 3 minutes<br>* balloon dilatation during ERCP using 10mm balloon<br>|
| Active Comparator: balloon dilatation for 6 minutes<br>Balloon dilatation of papilla of Vater for 6 minutes during ERCP using 10mm balloon Device: standard dilation balloon catheter (10 mm size) | Procedure: balloon dilatation for 6 minutes<br>* balloon dilatation during ERCP using 10mm balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute pancreatitis | Definition of acute pancreatitis: Serum lipase or amylase obtained 2 to 6 hours following ERCP + onset of abdominal pain after ERCP persisting for 24h+ need for analgesia | one to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of pancreatitis using the Imrie score system (according to Imrie et al.) | assessment of severity by Imrie score: mild pancreatitis defined by Imrie score <3, severe pancreatitis if Imrie score >=3 | one to 10 days | 
| endoscopic perforation | signs of perforation after ERCP, proven by CT scan or surgery | one to two days | 
| major bleeding | any bleeding events associated with ERCP. Drop of Hemoglobin of > 2g/dl and signs of bleeding | one to two days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic sphincterotomy, balloon dilation, adverse events, pancreatitis, bleeding