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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Puerta de Hierro University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by:
Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier:
NCT00270868
First received: December 27, 2005
Last updated: October 17, 2006
Last verified: October 2006
History of Changes
  Purpose

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.


Condition Intervention
Bile Duct Diseases
 Procedure: Double guide wire technique
Procedure: Standard bile duct cannulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Puerta de Hierro University Hospital:

Primary Outcome Measures:
  • Percentage of successful selective biliary cannulation

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 1050
Study Start Date: November 2004
Estimated Study Completion Date: November 2006
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270868

Locations
Spain
Central Hospital of Asturias
Oviedo, Asturias, Spain, 33006
León Hospital
Leon, León, Spain, 24071
Alcorcón Hospital Foundation
Alcorcón, Madrid, Spain, 28922
Navarra Hospital
Pamplona, Navarra, Spain, 31008
Puerta de Hierro University Hospital
Madrid, Spain, 28035
La Fe University Hospital
Valencia, Spain, 46009
Sponsors and Collaborators
Puerta de Hierro University Hospital
Carlos III Health Institute
Investigators
Principal Investigator: Luis E Abreu, MD Puerta de Hierro University Hospital. Madrid Health Service, Spain
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00270868     History of Changes
Other Study ID Numbers: PI 04/1942
Study First Received: December 27, 2005
Last Updated: October 17, 2006
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Puerta de Hierro University Hospital:
Double guide wire technique
Difficult selective biliary cannulation
ERCP
Attempts of cannulation
Post-ERCP complications.

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013