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RecruitingNot ApplicableNCT03977779

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

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

Sponsor

Institut Paoli-Calmettes

Enrollment

46 participants

Start Date

Jan 20, 2022

Study Type

INTERVENTIONAL

Conditions

Obstructive JaundiceBiliary StrictureSphincter of Oddi Dysfunction

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria4

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

DEVICEPlacement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography

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

Locations(1)

Institut Paoli Calmettes

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

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NCT03977779

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