Modified Double Wire Technique to Facilitate the Successful Cannulation

Air Force Military Medical University of People's Liberation Army

Status: Unknown

Conditions: Biliary Cannulation; Endoscopic Retrograde Cholangiopancreatography

Treatments: Procedure: Modified double wire technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03413111

KY20180081-1

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups

Modified double wire technique

Experimental group

Description:

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.

Treatment:

Procedure: Modified double wire technique

Standard double wire technique

No Intervention group

Description:

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.