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

NCT03977779 | Recruiting DMC

• 1 other identifier: ARCHIMEDE-PANCREAS-IPC
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Jaundice; Biliary Stricture; Sphincter of Oddi Dysfunction

Keywords

biodegradable stent; Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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

  Day 15

Study Arms (1)

Prophylactic biodegradable pancreatic stent placement

EXPERIMENTAL

Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography

Interventions

Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography DEVICE

The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography

Prophylactic biodegradable pancreatic stent placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Patients at risk of developing a Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (procedure and/or patient-related risk factors

You may not qualify if:

• Pregnant or breastfeeding women
• Recent diagnosis (\<1 month) of acute pancreatitis
• contraindication to endoscopy
• Hypersensitivity to indomethacine

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

Study Sites (1)

Institut Paoli Calmettes

Marseille, Provence-Alpes-Côte d'Azur Region, 13009, France

RECRUITING

MeSH Terms

Conditions

Jaundice, Obstructive; Sphincter of Oddi Dysfunction

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Central Study Contacts

Dominique Genre, MD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

Marc Giovannini, MD

CONTACT

giovanninim@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 6, 2019
• Study Start: January 20, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 15, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

FR (1)