Modified Double Wire Technique to Facilitate the Successful Cannulation

NCT03413111 | Unknown DMC

• 1 other identifier: KY20180081-1
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography

Keywords

ERCP; double guidewire technique

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• cannulation time of double wire technique

  3 hours

• Number of attempts for the successful CBD cannulation

  3 hours

• Overall cannulation success rate

  3 hours

• complication rates

  48 hours

Study Arms (2)

Modified double wire technique

EXPERIMENTAL

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

Standard double wire technique

NO INTERVENTION

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.

Interventions

Modified double wire technique PROCEDURE

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

Modified double wire technique

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

Central Study Contacts

Pan Yanglin, M.D.

CONTACT

+8613201851680; panyanglin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 29, 2018
• Study Start: February 2, 2018
• Primary Completion: January 16, 2019
• Study Completion: February 16, 2019
• Last Updated: May 17, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)