Modified Double Wire Technique to Facilitate the Successful Cannulation

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT03413111

Collaborator

(none)

130

Enrollment

Location

Arms

12.5

Anticipated Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biliary Cannulation Endoscopic Retrograde Cholangiopancreatography	Procedure: Modified double wire technique	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 2, 2018

Anticipated Primary Completion Date :

Jan 16, 2019

Anticipated Study Completion Date :

Feb 16, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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]
Overall cannulation success rate [3 hours]
complication rates [48 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endoscopic center, Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Air Force Military Medical University, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yanglin Pan, Associate Professor, Air Force Military Medical University, China

ClinicalTrials.gov Identifier:

NCT03413111

Other Study ID Numbers:

KY20180081-1

First Posted:

Jan 29, 2018

Last Update Posted:

May 17, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yanglin Pan, Associate Professor, Air Force Military Medical University, China

ERCP

double guidewire technique

Study Results

No Results Posted as of May 17, 2018