Modified Double Wire Technique to Facilitate the Successful Cannulation

NCT ID: NCT03413111

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2019-02-16

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Modified double wire technique

Intervention Type: PROCEDURE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Yanglin Pan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Endoscopic center, Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pan Yanglin, M.D.

Role: CONTACT

panyanglin@gmail.com

+8613201851680

Facility Contacts

Yanglin Pan, M.D.

Role: primary

panyanglin@gmail.com

86-29-84771536

Other Identifiers

KY20180081-1

Identifier Type: -

Identifier Source: org_study_id