Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03977779

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obstructive Jaundice Bile Duct Diseases Biliary Dyskinesia Biliary Stricture Biliary Tract Diseases Common Bile Duct Diseases Digestive System Diseases Hyperbilirubinemia Jaundice Jaundice, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Sphincter of Oddi Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Percentage of patients with a complete clearance of the biodegradable stent

    Time frame: Day 15

    The degradation of the stent will be evaluated both duodenoscopy/fluoroscopy and endoscopy 15 days after its placement

Study contacts

Contact information is provided by the study sponsor or research team.

Dominique Genre, MD

CONTACT

[email protected]

+33491223778

Marc Giovannini, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Official study title

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

Acronym: ARCHIMEDE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 6, 2019
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.