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

• Sponsor: Institut Paoli-Calmettes (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03977779
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 7.5
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Jaundice; Biliary Stricture; Sphincter of Oddi Dysfunction	Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
• Actual Study Start Date: Jan 20, 2022
• Anticipated Primary Completion Date: Jul 20, 2022
• Anticipated Study Completion Date: Sep 5, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prophylactic biodegradable pancreatic stent placement	Device: Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography; The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Paoli Calmettes	Marseille	Provence-Alpes-Côte d'Azur	France	13009

Sponsors and Collaborators

• Institut Paoli-Calmettes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Paoli-Calmettes
• ClinicalTrials.gov Identifier: NCT03977779
• Other Study ID Numbers: ARCHIMEDE-PANCREAS-IPC
• First Posted: Jun 6, 2019
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Institut Paoli-Calmettes: biodegradable stent; Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
• Additional relevant MeSH terms: Pancreatitis; Sphincter of Oddi Dysfunction; Jaundice; Jaundice, Obstructive

Study Results

No Results Posted as of Mar 9, 2022