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

Not Applicable

Recruiting

• Conditions: Biliary Stricture; Obstructive Jaundice; Sphincter of Oddi Dysfunction
• Interventions: Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography

• Registration Number: NCT03977779
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-06-05
• Study First Posted: 2019-06-06
• Study Start: 2022-01-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prophylactic biodegradable pancreatic stent placement	Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with a complete clearance of the biodegradable stent	Day 15	The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement

Trial Locations

Locations (1)

Institut Paoli Calmettes; 🇫🇷 Marseille, Provence-Alpes-Côte d'Azur, France