Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)
Recruitment status was Active, not recruiting
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.
Bile Duct Diseases
Procedure: Double guide wire technique
Procedure: Standard bile duct cannulation
|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.|
- Percentage of successful selective biliary cannulation
- 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
|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).
|Central Hospital of Asturias|
|Oviedo, Asturias, Spain, 33006|
|Leon, León, Spain, 24071|
|Alcorcón Hospital Foundation|
|Alcorcón, Madrid, Spain, 28922|
|Pamplona, Navarra, Spain, 31008|
|Puerta de Hierro University Hospital|
|Madrid, Spain, 28035|
|La Fe University Hospital|
|Valencia, Spain, 46009|
|Principal Investigator:||Luis E Abreu, MD||Puerta de Hierro University Hospital. Madrid Health Service, Spain|