Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

Institut Paoli-Calmettes46 enrolled

Overview

The use of an endoprothesis in a pancreatic duct is a measure to minimize the incidence and severity of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis. In this study we will evaluate the use of a Biodegradable Endoprothesis: Archimede Fast Biodegradable Pancreatic Stent in patients with high risk of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis.The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography. The efficacy and the security of the device will be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Obstructive Jaundice Biliary Stricture Sphincter of Oddi Dysfunction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age\>18 years * Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors Exclusion Criteria: * Pregnant or breastfeeding women * Recent diagnosis (\<1 month) of acute pancreatitis * contraindication to endoscopy * Hypersensitivity to indomethacine

Outcomes

Primary Outcomes

Percentage of patients with a complete clearance of the biodegradable stent

The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement

Time frame: Day 15

Central Contacts

Dominique Genre, MD

CONTACT

+33491223778 drci.up@ipc.unicancer.fr

Marc Giovannini, MD