Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire

Study Overview
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Brief Summary
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The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.

Detailed Description
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In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis. Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients

Official Title
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Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial

Conditions
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Pancreatitis

Intervention / Treatment
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* Device: Short guide wire rapid exchange
* Device: Long guide wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication to primary ERCP ASA (American Society of Anesthesiologists) 1, 2, 3 Exclusion Criteria: pancreas neoplasia pancreatitis ampulloma duodenum stenosis under mucous membrane haematoma

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short guide wire rapid exchange<br>Use of short guide wire rapid exchange to guide the cannulation during primary ERCP | Device: Short guide wire rapid exchange<br>* Use of short guide wire rapid exchange to guide the cannulation during primary ERCP<br>|
| Active Comparator: Long guide wire<br>Use of long wire to guide the cannulation during primary ERCP | Device: Long guide wire<br>* Use of long wire to guide the cannulation during primary ERCP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of cannulation | Time (in seconds) required to perform a complete and successful deep cannulation of the biliary papilla and the biliary tree assessed by timing it and reporting it in the prefashioned database | 8 hours from intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post ERCP pancreatitis | Incidence of post ERCP pancreatitis | 8 hours post ERCP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guide wire cannulation ERCP, Time of cannulation, Rapid exchange guide wire, Guide wire