Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)

Bile Duct Diseases Clinical Trial

Official title: Double Guide Wire Placement Compared With Conventional Method in Cases of Difficult Common Bile Duct Cannulation in Endoscopic Retrograde Cholangiopancreatography Procedures. A Controlled Multicentred Randomized Trial.

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to determine if the double guide wire technique is more effective than the conventional method in those cases of difficult selective biliary cannulation in the ERCP procedures.

Clinical Trial Description

Complications associated with ERCP have been related with certain characteristics of the procedure. One is the number of attempts of selective biliary cannulation. Our hypothesis is that double guide wire placement could be a useful technique for selective biliary cannulation in those cases of difficult ERCP procedures, reducing the number of cannulation attempts and the complication associated with the procedure.

We are conducting a controlled prospective multicentre randomized study to compare the double guide wire technique with the conventional method in two groups previously randomized after presenting a difficult selective biliary cannulation under the conventional method. The study is carried out in six public Hospitals from Spain. Assignation is concealed to both groups, and the expected study period is 18 months for a number of randomized patients equal or over 262 (statistical power of 90% with an α-error of 0.05, to detect a success rate of 74% in the group undergoing double guide wire technique against a success rate of 60% in the control group). The main outcome variables are successful selective biliary cannulation (primary outcome variable), number of attempts and morbimortality associated in both groups (secondary outcome variables). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases

• NCT number: NCT00270868
• Study type: Interventional
• Source: Puerta de Hierro University Hospital
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2004
• Completion date: November 2006