Pancreatic Sphincterotomy Versus Double Wire Technique in Difficult Cannulation

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Procedure: Biliary cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02548884

Difficult cannulation

Details and patient eligibility

About

The purpose of the study is to compare two different techniques (pancreatic sphincterotomy (PS) and double wire technique (DGW)) regarding the risk of post-ERCP pancreatitis (PEP) and the success of cannulation in difficult cannulation. For the study, the difficult cannulation is de-fined as situation when the common bile duct has not been cannulated in five minutes, after five attempts or after two pancreatic guide wire passages or when any of those limits is exceeded. The two techniques, the PS and the DGW, will be compared in random fashion. The primary end-point is the risk of PEP .

Enrollment: 1,190 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Naive papilla, ERCP indication common bile duct cannulation

Exclusion criteria

• No consent to the study
• Ongoing pancreatitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,190 participants in 2 patient groups

Pancreatic sphincterotomy

Active Comparator group

Description:

Pancreatic sphincterotomy technique used in difficult biliary cannulation

Treatment:

Procedure: Biliary cannulation

Double guide wire

Active Comparator group

Description:

Double guide wire technique used in difficult biliary cannulation

Treatment:

Procedure: Biliary cannulation