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Sponsors and Collaborators: |
Puerta de Hierro University Hospital Carlos III Health Institute |
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Information provided by: | Puerta de Hierro University Hospital |
ClinicalTrials.gov Identifier: | NCT00270868 |
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 |
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Bile Duct Diseases |
Procedure: Double guide wire technique Procedure: Standard bile duct cannulation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 1050 |
Study Start Date: | November 2004 |
Estimated Study Completion Date: | November 2006 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Puerta de Hierro University Hospital | |
Madrid, Spain, 28035 | |
La Fe University Hospital | |
Valencia, Spain, 46009 | |
Spain, Asturias | |
Central Hospital of Asturias | |
Oviedo, Asturias, Spain, 33006 | |
Spain, León | |
León Hospital | |
Leon, León, Spain, 24071 | |
Spain, Madrid | |
Alcorcón Hospital Foundation | |
Alcorcón, Madrid, Spain, 28922 | |
Spain, Navarra | |
Navarra Hospital | |
Pamplona, Navarra, Spain, 31008 |
Principal Investigator: | Luis E Abreu, MD | Puerta de Hierro University Hospital. Madrid Health Service, Spain |
Study ID Numbers: | PI 04/1942 |
Study First Received: | December 27, 2005 |
Last Updated: | October 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00270868 |
Health Authority: | Spain: Spanish Agency of Medicines |
Double guide wire technique Difficult selective biliary cannulation ERCP Attempts of cannulation Post-ERCP complications. |
Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases |