Overview

This trial is active, not recruiting.

Condition bile duct diseases
Treatments double guide wire technique, standard bile duct cannulation
Sponsor Puerta de Hierro University Hospital
Collaborator Carlos III Health Institute
Start date November 2004
End date November 2006
Trial size 1050 participants
Trial identifier NCT00270868, PI 04/1942

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose treatment

Primary Outcomes

Measure
Percentage of successful selective biliary cannulation
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Luis E Abreu, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Puerta de Hierro University Hospital.