Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

Not Applicable

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography
• Interventions: Procedure: Biliary cannulation

• Registration Number: NCT02548884
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-03
• Study First Submitted QC: 2015-09-11
• Study First Posted: 2015-09-14
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-18
• Last Update Posted: 2021-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1190

Inclusion Criteria

• Naive papilla, ERCP indication common bile duct cannulation

Exclusion Criteria

• No consent to the study
• Ongoing pancreatitis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double guide wire	Biliary cannulation	Double guide wire technique used in difficult biliary cannulation
Pancreatic sphincterotomy	Biliary cannulation	Pancreatic sphincterotomy technique used in difficult biliary cannulation

Primary Outcome Measures

Name	Time	Method
Post ERCP pancreatitis defined by ESGE guidelines published 2014	48 hours	Acute pancreatitis within 48 hours post ERCP. Post-ERCP pancreatitis (PEP) is defined as the presence of abdominal pain attributable to acute pancreatitis, together with a need for an unplanned hospitalization or an extension of a planned hospitalization by at least 2 days, and a serum /plasma amylase at least 3 times above the upper limit of normal at 24 hours after the procedure.

Secondary Outcome Measures

Name	Time	Method
Biliary cannulation success within 15 minutes after randomization	15 minutes	After randomization, timing to get the wire in biliary duct. First assessed the number of procedures succeeded in 15 minutes.
Biliary cannulation success, total number	2 hours	The total number of successful biliary cannulations after randomization

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland