Modified Double Wire Technique to Facilitate the Successful Cannulation

Not Applicable

• Conditions: Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography

• Registration Number: NCT03413111
• 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 common bile duct (CBD) with a sphincterotome preloaded with another guidewire often becomes feasible. However, because of the small opening of the papilla, sometimes it is technically challenging for the following cannulation of CBD with the sphincterotome and PD guidewire in the same working channel. We hypothesized that a tiny cut of the opening of papilla, without the injury of pancreatic sphincter, may facilitate the success of DWT and shorten the overall cannulation time.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Status Verified: 2018-02
• Study Start: 2018-02-02
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-17
• Primary Completion: 2019-01-16
• Study Completion: 2019-02-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Patients aged 18-90 with native papilla;
• CBD as the targeted duct;
• Inadvertent PD cannulation more than twice;
• Selective biliary cannulation was not possible within 10 minutes or 5 attempts.

Exclusion Criteria

• Contraindications of ERCP;
• Major or minor PD as the targeted duct;
• NK or transpancreatic precut before enrollment ;
• Surgically altered GI anatomy;
• Papillary carcinoma or stone impaction within papilla or fistula in papilla;
• Prior endoscopic sphincterotomy;
• Complete pancreas divisum;
• failure of pancreatic duct cannulation;
• Pregnant or breastfeeding women;
• Unwilling or inability to provide consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Success rate of double wire technique	3 hours	the rate of successful cannulation of CBD for ≤5 attempts by using the sphincterotome alongside the PD guidewire.

Secondary Outcome Measures

Name	Time	Method
Overall cannulation success rate	3 hours
cannulation time of double wire technique	3 hours	the time taken from the touching of papilla by the sphincterotome alongside the PD guidewire to the successful cannulation of CBD
Number of attempts for the successful CBD cannulation	3 hours
complication rates	48 hours

Trial Locations

Locations (1)

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