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Search / Trial NCT04049955

Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Aug 6, 2019

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Trial Information

Current as of May 21, 2025

Completed

Keywords

Sleeve Gastrostomy Endoscopy Fistula Double Pig Tail Stents

ClinConnect Summary

Partially or fully covered stents are the most used method, but are not supported by any comparative studies. Their results are inconstant and the closure rate is estimated between 15 and 100%, with a hazardous median healing time. This method is associated with frequent complications, such as spontaneous migrations, impactions or ulcerations responsible for potentially fatal hematemesis. The preliminary results of using OTSC clips (OVESCO®) seem encouraging, but this technique requires external drainage to obtain a collection free from infection. A new approach is to perform an internal dr...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • Any major patient hospitalized for a symptomatic fistula after sleeve gastrectomy, outside the exclusion criteria, is eligible.
  • • Free, informed and signed consent
  • • Affiliation to the social security system
  • Exclusion Criteria:
  • • Other surgery than Sleeve gastrectomy
  • • Fistula located at a site other than the upper pole of the staple line
  • • Fistulization on the upper diaphragmatic floor
  • • Fistulous orifice larger than 25 mm
  • • Pregnancy
  • • Patient under guardianship or curators or deprived of public law

About Centre Hospitalier Universitaire, Amiens

The Centre Hospitalier Universitaire (CHU) Amiens is a leading academic medical center in France dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on multidisciplinary collaboration, CHU Amiens integrates patient care, education, and research to enhance treatment outcomes and improve patient quality of life. The institution is committed to ethical standards and regulatory compliance in its clinical research endeavors, aiming to contribute significantly to the medical community and the development of new therapeutic approaches. By fostering partnerships with various stakeholders, CHU Amiens strives to translate scientific discoveries into practical applications that benefit patients and healthcare systems alike.

Locations

Amiens, Picardie, France

Patients applied

0 patients applied

Trial Officials

Sami Hakim, MD

Principal Investigator

CHU Amiens

Jean-Marc Regimbeau, Pr

Principal Investigator

CHU Amiens

Lionel Rebibo, MD

Principal Investigator

Hopital Bichat, Paris

Jean-Christophe Duchmann, MD

Principal Investigator

Centre Hospitalier Compiègne

Jonathan Levy, MD

Principal Investigator

Clinique des Cèdres Chât Alliez, Cornebarrieu

Jean-François Bourgaux, MD

Principal Investigator

CHRU Nimes

Ion Donici, MD

Principal Investigator

CHRU Nimes

Vincent Quentin, MD

Principal Investigator

CH Saint Brieux

Fabien Fumex, MD

Principal Investigator

Hopital Jean Mermoz, Lyon

Gaetan Singier, MD

Principal Investigator

Hopital Jean Mermoz, Lyon

Cécile Gomercic, MD

Principal Investigator

CHU Nice

Antonio Iannelli, MD

Principal Investigator

CHU Nice

Claire Blanchard, MD

Principal Investigator

Nantes University Hospital

Timothée Wallenhorst, MD

Principal Investigator

CHU Rennes

Damien Bergeat, MD

Principal Investigator

CHU Rennes

Davide Mazza, MD

Principal Investigator

CH TOULON

Stéphane Koch, MD

Principal Investigator

CHRU Besançon

Nicolas Bouviez, MD

Principal Investigator

CHRU Besançon

Antoine Soprani, MD

Principal Investigator

Clinique Paris-Bercy

Clément Subtil, MD

Principal Investigator

University Hospital, Bordeaux

Ulriikka Chaput, MD

Principal Investigator

Hopital Saint Antoine, Paris

Jérome Rivory, MD

Principal Investigator

Hopital Edouard Herriot - Lyon

Maud Robert, MD

Principal Investigator

Hopital Edouard Herriot - Lyon

Franck Cholet, MD

Principal Investigator

CHU Brest

Jérémie Thereaux, MD

Principal Investigator

CHU Brest

Jean-Christophe Valats, MD

Principal Investigator

University Hospital, Montpellier

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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