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

October 17, 2006 updated by: Puerta de Hierro University Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

1050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28035
        • Puerta de Hierro University Hospital
      • Valencia, Spain, 46009
        • La Fe University Hospital
    • Asturias
      • Oviedo, Asturias, Spain, 33006
        • Central Hospital of Asturias
    • León
      • Leon, León, Spain, 24071
        • León Hospital
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Alcorcón Hospital Foundation
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Navarra Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of successful selective biliary cannulation

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Puerta de Hierro University Hospital

Collaborators

Carlos III Health Institute

Investigators

  • Principal Investigator: Luis E Abreu, MD, Puerta de Hierro University Hospital. Madrid Health Service, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

November 1, 2006

Study Registration Dates

First Submitted

December 27, 2005

First Submitted That Met QC Criteria

December 27, 2005

First Posted (ESTIMATE)

December 28, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

October 18, 2006

Last Update Submitted That Met QC Criteria

October 17, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI 04/1942

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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