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

Not Applicable

Completed

• Conditions: Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography

• Registration Number: NCT03707613
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Study Start: 2018-10-15
• Study First Posted: 2018-10-16
• Primary Completion: 2019-08-28
• Study Completion: 2019-09-29
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Successful cannulation of bile duct within 5min or 5 attempts of cannulation	3 hours	It was defined by assurance of entering bile duct through cholangiogram during fluoroscopy.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Endoscopic center, Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China