Clinical trial NCT00270868: Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bile Duct Diseases
Keywords: Double guide wire technique
Difficult selective biliary cannulation
ERCP
Attempts of cannulation
Post-ERCP complications.
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
Collaborators: name: Carlos III Health Institute
First posted: 2005-12-28
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of successful selective biliary cannulation
Secondary outcomes:
measure: Number of attempts and time of cannulation.
measure: Morbimortality associated in both groups at hospital discharge and 4 weeks after ERCP procedure
measure: Factors associated with successful cannulation for both techniques
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Central Hospital of Asturias
state: Asturias
city: Leon
country: Spain
facility: León Hospital
state: León
city: Alcorcón
country: Spain
facility: Alcorcón Hospital Foundation
state: Madrid
city: Pamplona
country: Spain
facility: Navarra Hospital
state: Navarra
city: Madrid
country: Spain
facility: Puerta de Hierro University Hospital
city: Valencia
country: Spain
facility: La Fe University Hospital
Study officials:
affiliation: Puerta de Hierro University Hospital. Madrid Health Service, Spain
name: Luis E Abreu, MD
role: PRINCIPAL_INVESTIGATOR
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