Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Study Overview
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Brief Summary
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Selective cannulation is considered the most challenging step for most of endoscopic retrograde cholangiopancreatography (ERCP). Wire-guided cannulation is the standard technique for initial cannulation. When meeting difficulty, double wire technique (DWT) is widely used. With one guidewire occupying pancreatic duct(PD) , the following cannulation of CBD with a sphincterome preloaded with another guidewire often becomes feasible. When performing DWT, a sphincterotome should enter the common duct of papilla through a small orifice and be placed in the left and upper direction of PD guidewire. Then another guidewire can be advanced into bile duct. As an advanced cannulation technique, DWT can be successfully performed in up to 80% of difficult patients. However, it can be technically difficult, especially for trainees or endoscopists without adequate experience. Here we planned to prospectively record the procedures of double-wire cannulation by two trainees without prior experience of DWT. This study aims to delinate the learning curve of DWT and its safety by trainees.

Official Title
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Learning Curve of Double-wire Cannulation Technique During Endoscopic Retrograde Cholangiopancreatography(ERCP): a Pilot Study

Conditions
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Biliary Cannulation, Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Procedure: DWT learning curve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-90 with native papilla patients with diffcult cannulation of bile duct Inadvertent pancreatic duct cannulation Exclusion Criteria: Contraindications of ERCP Major or minor pancreatic duct as the targeted duct Prior EST or needle-knife precut before DWT Surgically altered gastrointestinal anatomy Papillary carcinoma or stone impaction within papilla Complete pancreas divisum Pregnant or breastfeeding women Unwilling or inability to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DWT learning curve<br>Initial cannulation is performed with a wire-guided sphincterotome by a trainee. If the cannulation proves difficult (cannulation time >10min, cannulation attemtps >5 or inadvertent PD cannulation >1) and PD is inadvertently entered, DWT will be performed by one of the two trainees. If DWT fails within 5min or 5 attempts, a trainer will take over and continue the cannulation. To prevent PEP, all patients receive prophylactic PD stent and post-ERCP rectal indomethacin. Aggressive hydartion will be administrated at the discretion of endoscopists. | Procedure: DWT learning curve<br>* trainees learn to perform DWT after unsuccessful initial cannulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cannulation of bile duct within 5min or 5 attempts of cannulation | It was defined by assurance of entering bile duct through cholangiogram during fluoroscopy. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful cannulation time with DWT by trainees | Successful cannulation time was defined by the time taken from the begining of DWT to entering bile duct successfully | 3 hours | 
| Cannulation attempts with DWT by trainees | One cannulation attempt was defined by touching papilla for more than 5 seconds. | 3 hours | 
| Precut rate | Precut includes the procedure of cannulation involving needle knife or dual knife and transpancreatic precut by a sphincterotome. | 3 hours | 
| post-ERCP pancreatitis(PEP) | PEP is defined according to Cotton's criteria. The severity classification is based on revised Atlanta criteria. | 48 hours | 
| Overall ERCP-related complications | Overall ERCP-related complations include PEP, bleeding, perforation, cholangitis and others, which is defined by Cotton's criteria. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, double guidewire technique, learning curve