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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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.

Conditions
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Bile Duct Diseases

Intervention / Treatment
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* Procedure: Double guide wire technique
* Procedure: Standard bile duct cannulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Double guide wire technique|nan|
|Procedure: Standard bile duct cannulation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of successful selective biliary cannulation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Double guide wire technique, Difficult selective biliary cannulation, ERCP, Attempts of cannulation, Post-ERCP complications.