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

Not Applicable

• Conditions: Bile Duct Diseases

• Registration Number: NCT00270868
• Lead Sponsor: Puerta de Hierro University Hospital

Brief 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.

Detailed 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 Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-12-27
• Study First Submitted QC: 2005-12-27
• Study First Posted: 2005-12-28
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-17
• Last Update Posted: 2006-10-18
• Study Completion: 2006-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

Inclusion Criteria

• Age over 18 years
• Clinical and/or radiological suspicion of Bile Duct Diseases which require ERCP procedure with intention of selective biliary cannulation
• Patients must be admitted in the participant hospitals of the investigators units
• Written informed consent of the patient, relative or legal tutor

Exclusion Criteria

• Previous biliary or pancreatic sphincterotomy
• Previous pneumatic dilatation of duodenal papilla
• Presence of biliary-digestive derivation
• Previous diagnosis or suspected pancreas divisum
• Use of any biliary or pancreatic stent in the last 6 months
• Use of any drug aimed to reduce post-ERCP pancreatitis
• Pregnancy or maternal feeding
• Previous inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of successful selective biliary cannulation

Secondary Outcome Measures

Name	Time	Method
Number of attempts and time of cannulation.
Morbimortality associated in both groups at hospital discharge and 4 weeks after ERCP procedure
Factors associated with successful cannulation for both techniques

Trial Locations

Locations (6)

Central Hospital of Asturias; 🇪🇸 Oviedo, Asturias, Spain

Alcorcón Hospital Foundation; 🇪🇸 Alcorcón, Madrid, Spain

Puerta de Hierro University Hospital; 🇪🇸 Madrid, Spain

La Fe University Hospital; 🇪🇸 Valencia, Spain

León Hospital; 🇪🇸 Leon, León, Spain

Navarra Hospital; 🇪🇸 Pamplona, Navarra, Spain