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

Summary

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.

Conditions

• Gastrostomy
• Fistula

Interventions

PROCEDURE

endoscopy

In the case of a well-organized abscessed collection responsible for sepsis instability, or poorly organized collection, an external drainage is carried out, by a radiological or a surgical way. The endoscopy is performed 7 days later. If there is no hemodynamic instability and in presence of a well-organized abscessed collection, a first-line endoscopy is carried out. After laying 2 double pig tail stents, the external drainage is removed 2 to 7 days later.

Sponsors & Collaborators

• Bichat Hospital

  collaborator OTHER

• centre hospitalier de Compiegne

  collaborator UNKNOWN

• clinique des cedres, Cornebarrieu

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Nīmes

  collaborator OTHER

• Centre Hospitalier de Saint-Brieuc

  collaborator OTHER

• Hospital Prive Jean Mermoz

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• Centre Hospitalier Toulon

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• Clinique Paris-Bercy

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Saint Antoine University Hospital

  collaborator OTHER

• Hôpital Edouard Herriot

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Centre Hospitalier Universitaire, Amiens

  lead OTHER

Principal Investigators

• Sami Hakim, MD · CHU Amiens

• Jean-Marc Regimbeau, Pr · CHU Amiens

• Lionel Rebibo, MD · Hopital Bichat, Paris

• Jean-Christophe Duchmann, MD · Centre Hospitalier Compiègne

• Jonathan Levy, MD · Clinique des Cèdres Chât Alliez, Cornebarrieu

• Jean-François Bourgaux, MD · CHRU Nimes

• Ion Donici, MD · CHRU Nimes

• Vincent Quentin, MD · CH Saint Brieux

• Fabien Fumex, MD · Hopital Jean Mermoz, Lyon

• Gaetan Singier, MD · Hopital Jean Mermoz, Lyon

• Cécile Gomercic, MD · CHU NICE

• Antonio Iannelli, MD · CHU NICE

• Claire Blanchard, MD · Nantes University Hospital

• Timothée Wallenhorst, MD · CHU Rennes

• Damien Bergeat, MD · CHU Rennes

• Davide Mazza, MD · CH TOULON

• Stéphane Koch, MD · CHRU Besançon

• Nicolas Bouviez, MD · CHRU Besançon

• Antoine Soprani, MD · Clinique Paris-Bercy

• Clément Subtil, MD · University Hospital, Bordeaux

• Ulriikka Chaput, MD · Hopital Saint Antoine, Paris

• Jérome Rivory, MD · Hopital Edouard Herriot - Lyon

• Maud Robert, MD · Hopital Edouard Herriot - Lyon

• Franck Cholet, MD · CHU Brest

• Jérémie Thereaux, MD · CHU Brest

• Jean-Christophe Valats, MD · University Hospital, Montpellier

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-01

Primary Completion

2021-07-01

Completion

2021-11-01

Countries

• France

Study Locations