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

NCT ID: NCT03977779

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2024-12-15

Brief Summary

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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

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Conditions

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Obstructive Jaundice Biliary Stricture Sphincter of Oddi Dysfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prophylactic biodegradable pancreatic stent placement

Group Type EXPERIMENTAL

Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Paoli Calmettes

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

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique Genre, MD

Role: CONTACT

+33491223778

Marc Giovannini, MD

Role: CONTACT

Facility Contacts

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GENRE Dominique, MD

Role: primary

+ 33 4 91 22 37 78

GOUARNE Caroline, PhD

Role: backup

+ 33 4 91 22 37 78

Other Identifiers

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ARCHIMEDE-PANCREAS-IPC

Identifier Type: -

Identifier Source: org_study_id

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