Modified Double Wire Technique to Facilitate the Successful Cannulation

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

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.

Study Overview

• Status: Unknown
• Conditions: Endoscopic Retrograde Cholangiopancreatography; Biliary Cannulation
• Intervention / Treatment: Procedure: Modified double wire technique

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Endoscopic center, Xijing Hospital of Digestive Diseases
      • Contact: Yanglin Pan, M.D.; Phone Number: 86-29-84771536; Email: panyanglin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified double wire technique; A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, a tiny cut of opening, with the length of 5mm, was performed with the sphincterotome. Then the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, needle knife (NK) precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP.	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.
No Intervention: Standard double wire technique; A sphincterotome was used for standard wire-guided cannulation. If the difficult biliary cannulation occurred and guidewire inadvertently entered PD, the guidewire was left in PD and the sphincterotome withdrew. The same sphincterotome was re-inserted in the working channel alongside the first guidewire, another wire is used for wire-guided selective cannulation of CBD. If the cannulation of CBD was not successful within 5 attempts, other cannulation techniques (e.g. transpancreatic precut, NK precut or over-the stent precut) would be tried at the discretion of endoscopists. A 5Fr, unflanged PD stent was placed before the ending of ERCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of attempts for the successful CBD cannulation		3 hours
Overall cannulation success rate		3 hours
complication rates		48 hours

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2018
• Primary Completion (Anticipated): January 16, 2019
• Study Completion (Anticipated): February 16, 2019

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: ERCP; double guidewire technique
• Other Study ID Numbers: KY20180081-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No