Back to resultsEvaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis (ARCHIMEDE)
Primary Purpose
Obstructive Jaundice, Biliary Stricture, Sphincter of Oddi Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
Sponsored by
About this trial
This is an interventional prevention trial for Obstructive Jaundice focused on measuring biodegradable stent, Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
Eligibility Criteria
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
Sites / Locations
- Institut Paoli CalmettesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prophylactic biodegradable pancreatic stent placement
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03977779
Brief Title
Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
Acronym
ARCHIMEDE
Official Title
Prospective Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Anticipated)
Study Completion Date
September 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Jaundice, Biliary Stricture, Sphincter of Oddi Dysfunction
Keywords
biodegradable stent, Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic biodegradable pancreatic stent placement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography
Intervention Description
The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
Primary Outcome Measure Information:
Title
Percentage of patients with a complete clearance of the biodegradable stent
Description
The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement
Time Frame
Day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Genre, MD
Phone
+33491223778
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marc Giovannini, MD
Email
giovanninim@ipc.unicancer.fr
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
State/Province
Provence-Alpes-Côte d'Azur
ZIP/Postal Code
13009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GENRE Dominique, MD
Phone
+ 33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
First Name & Middle Initial & Last Name & Degree
GOUARNE Caroline, PhD
Phone
+ 33 4 91 22 37 78
Email
drci.up@ipc.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Use of a Biodegradable Endoprothesis in the Prevention of Post-Endoscopic Retrograde CholoangioPancreatography Pancreatitis
We'll reach out to this number within 24 hrs