Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)
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|ClinicalTrials.gov Identifier: NCT00270868|
Recruitment Status : Unknown
Verified October 2006 by Puerta de Hierro University Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 28, 2005
Last Update Posted : October 18, 2006
|Condition or disease||Intervention/treatment|
|Bile Duct Diseases||Procedure: Double guide wire technique Procedure: Standard bile duct cannulation|
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 (Clinical Trial)|
|Estimated Enrollment :||1050 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Study Start Date :||November 2004|
|Estimated Study Completion Date :||November 2006|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270868
|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|