Early Precut in Difficult Biliary Cannulation

Not Applicable

Terminated

• Conditions: Common Bile Duct Diseases
• Interventions: Procedure: Prolonged cannulation attempts; Procedure: Early Precut

• Registration Number: NCT02596646
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.

Detailed Description

In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2015-09-07
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-04
• Last Update Submitted: 2015-11-05
• Last Update Posted: 2015-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Not specified
• Target Recruitment: 375

Inclusion Criteria

• 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.

Exclusion Criteria

• active cholangitis or pancreatitis
• chronic pancreatitis,
• previous sphincterotomy,
• prior gastric surgery,
• coagulopathy,
• severe comorbidity (need for tracheal intubation)
• patients who refused or were unable to give informed consent.
• patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
• detection of ampulloma or peri-papillary diverticula during ERCP.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Prolonged cannulation attempts	Prolonged cannulation attempts
Group A	Early Precut	Early Precut

Primary Outcome Measures

Name	Time	Method
Incidence of PEP	24 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of overall complications	24 hours	The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy