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

NCT04049955 | Completed

• 1 other identifier: PI2018_843_0017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

sleeve gastrostomy; endoscopy; fistula; double pig tail stents

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Fistula Healing at week 18

  Number of Participants with Healing at week 18

  week 18 after endoscopy

Secondary Outcomes (5)

• Number of Participants with Fistula Healing at week 6

  week 6 after endoscopy

• Number of Participants with Fistula Healing at week 12

  week 12 after endoscopy

• Number of Participants with Fistula delay

  up to week 18 after endoscopy

• Number of Participants with gastric stenosis

  up to week 18 after endoscopy

• Measure of length of hospital stay

  up to week 18 after endoscopy

Study Arms (1)

endoscopy

EXPERIMENTAL

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.

Procedure: endoscopy

Interventions

endoscopy PROCEDURE

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.

endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Free, informed and signed consent
• Affiliation to the social security system
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• Bichat Hospital: collaborator
• centre hospitalier de Compiegne: collaborator
• clinique des cedres, Cornebarrieu: collaborator
• Centre Hospitalier Universitaire de Nīmes: collaborator
• Centre Hospitalier de Saint-Brieuc: collaborator
• Hospital Prive Jean Mermoz: collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Nantes University Hospital: collaborator
• Rennes University Hospital: collaborator
• Centre Hospitalier Toulon: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator
• Clinique Paris-Bercy: collaborator
• University Hospital, Bordeaux: collaborator
• Saint Antoine University Hospital: collaborator
• Hôpital Edouard Herriot: collaborator
• University Hospital, Brest: collaborator
• University Hospital, Montpellier: collaborator

Study Sites (1)

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

Location

MeSH Terms

Conditions

Fistula

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sami Hakim, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Jean-Marc Regimbeau, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Lionel Rebibo, MD

  Hopital Bichat, Paris

  PRINCIPAL INVESTIGATOR

• Jean-Christophe Duchmann, MD

  Centre Hospitalier Compiègne

  PRINCIPAL INVESTIGATOR

• Jonathan Levy, MD

  Clinique des Cèdres Chât Alliez, Cornebarrieu

  PRINCIPAL INVESTIGATOR

• Jean-François Bourgaux, MD

  CHRU Nimes

  PRINCIPAL INVESTIGATOR

• Ion Donici, MD

  CHRU Nimes

  PRINCIPAL INVESTIGATOR

• Vincent Quentin, MD

  CH Saint Brieux

  PRINCIPAL INVESTIGATOR

• Fabien Fumex, MD

  Hopital Jean Mermoz, Lyon

  PRINCIPAL INVESTIGATOR

• Gaetan Singier, MD

  Hopital Jean Mermoz, Lyon

  PRINCIPAL INVESTIGATOR

• Cécile Gomercic, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

• Antonio Iannelli, MD

  CHU NICE

  PRINCIPAL INVESTIGATOR

• Claire Blanchard, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Timothée Wallenhorst, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Damien Bergeat, MD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Davide Mazza, MD

  CH TOULON

  PRINCIPAL INVESTIGATOR

• Stéphane Koch, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Nicolas Bouviez, MD

  CHRU Besançon

  PRINCIPAL INVESTIGATOR

• Antoine Soprani, MD

  Clinique Paris-Bercy

  PRINCIPAL INVESTIGATOR

• Clément Subtil, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

• Ulriikka Chaput, MD

  Hopital Saint Antoine, Paris

  PRINCIPAL INVESTIGATOR

• Jérome Rivory, MD

  Hopital Edouard Herriot - Lyon

  PRINCIPAL INVESTIGATOR

• Maud Robert, MD

  Hopital Edouard Herriot - Lyon

  PRINCIPAL INVESTIGATOR

• Franck Cholet, MD

  CHU Brest

  PRINCIPAL INVESTIGATOR

• Jérémie Thereaux, MD

  CHU Brest

  PRINCIPAL INVESTIGATOR

• Jean-Christophe Valats, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: August 8, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)