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NCT04049955: bartoli

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

Completed NA Last updated 18 January 2023
What this trial tests

NA trial testing endoscopy in Gastrostomy in 150 participants. Completed in 1 November 2021.

Timeline
1 August 2019
Primary endpoint
1 July 2021
1 November 2021

Quick facts

Lead sponsorCentre Hospitalier Universitaire, Amiens
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment150
Start date1 August 2019
Primary completion1 July 2021
Estimated completion1 November 2021
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Universitaire, Amiens

Who can join

18 and older, any sex, with Gastrostomy or Fistula. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. The main complication is the occurrence of upper fistula (2%), and may be responsible of several deaths. There is no consensus on medical, radiological and surgical management of fistula. It depends on the resources of each center and is based on a low level evidence The inconstant efficacy of the endoscopic treatment by closing fistula (digestive stents, clips, glue) motivates a new endoscopic approach. It consists of an internal drainage of the collection by using double pigtail stents through the fistulous orifice.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of endoscopy

Trials testing the same drug.

Other recruiting trials for Gastrostomy

Currently open trials in the same condition.

Other Centre Hospitalier Universitaire, Amiens trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04049955.

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