Modified Double Wire Technique to Facilitate the Successful Cannulation

Endoscopic Retrograde Cholangiopancreatography Clinical Trial

Official title:

Modified Double Wire Technique to Facilitate the Successful Cannulation: Prospective Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03413111
• Other study ID #: KY20180081-1
• Status: Recruiting
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: February 16, 2019

Study information

• Verified date: February 2018
• Source: Fourth Military Medical University
• Contact: Pan Yanglin, M.D.
• Phone: +8613201851680
• Email: panyanglin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Cannulation
• Endoscopic Retrograde Cholangiopancreatography

Intervention

Procedure:
• Modified double wire technique
For experimental arm, a tiny cut of papilla orifice, with the length of 5mm, was performed by sphincterotome before the double wire cannulation.

Locations

Country	Name	City	State
China	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of double wire technique	the rate of successful cannulation of CBD for =5 attempts by using the sphincterotome alongside the PD guidewire.	3 hours
Secondary	cannulation time of double wire technique	the time taken from the touching of papilla by the sphincterotome alongside the PD guidewire to the successful cannulation of CBD	3 hours
Secondary	Number of attempts for the successful CBD cannulation		3 hours
Secondary	Overall cannulation success rate		3 hours
Secondary	complication rates		48 hours