Bile Duct Diseases Clinical Trial
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.
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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