Does Pancreatic Stent Decrease the Risk of Pancreatitis After Pancreatic Sphincterotomy for Difficult Cannulation?

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Device: Biliary cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04408482

3509/2019

Details and patient eligibility

About

The purpose of the study is to compare the risk of PEP after pancreatic sphincterotomy performed for difficult cannulation in a group of patients with and in a group of patients without placement of a prophylactic pancreatic stent. The definition of difficult cannulation is defined according to the literature.

Enrollment: 268 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Consecutive patients with naïve papilla presenting to ERCP with indication of common bile duct (CBD) cannulation will be considered to the study.

Exclusion criteria

• Exclusion criteria are age below 18 years, acute pancreatitis and no consent to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

Pancreatic sphincterotomy

Active Comparator group

Description:

Pancreatic sphincterotomy performed in difficult cannulation

Treatment:

Device: Biliary cannulation

Pancreatic sphincterotomy + pancreatic stent

Active Comparator group

Description:

Pancreatic sphincterotomy performed in difficult cannulation + pancreatic stent placement

Treatment:

Device: Biliary cannulation