Post-ERCP Pancreatitis Prevention by Stent Insertion (PEPSI)

Technical University of Munich

Status: Completed

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Device: Stent insertion into the main pancreatic duct

Study type: Interventional

Funder types: Other

Identifiers

NCT01673763

240179

Details and patient eligibility

About

The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.

Enrollment: 169 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
• age > 17 years
• signed informed consent

Exclusion criteria

• intention to intervene main pancreatic duct
• age < 18 years
• pregnancy
• absent of signed informed consent

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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169 participants in 2 patient groups

Stent

Active Comparator group

Description:

Stent insertion into the main pancreatic duct

Treatment:

Device: Stent insertion into the main pancreatic duct

No stent

No Intervention group

Description:

No stent insertion into the main pancreatic duct