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

NCT ID: NCT04049955

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2021-11-01

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.

Detailed Description

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 drainage of the peri-orificial collection by using double pigtail stents through the fistulous orifice and to direct the fistula closure from the outside to the inside. This endoscopic treatment, combined with nutritional support and initial antibiotic therapy, allows rapid weaning of external drainage and short healing times. CT and endoscopic evaluation are needed at the sixth week for stents removal in the event of a favorable evolution. In the opposite case, a second endoscopic treatment is performed. In case of unfavorable evolution, a radical surgical treatment, in the absence of endoscopic alternative, will be achieved.

Conditions

Gastrostomy; Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

endoscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bichat Hospital

OTHER

Sponsor Role: collaborator

centre hospitalier de Compiegne

UNKNOWN

Sponsor Role: collaborator

clinique des cedres, Cornebarrieu

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Saint-Brieuc

OTHER

Sponsor Role: collaborator

Hospital Prive Jean Mermoz

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: collaborator

Centre Hospitalier Toulon

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: collaborator

Clinique Paris-Bercy

OTHER

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: collaborator

Saint Antoine University Hospital

OTHER

Sponsor Role: collaborator

Hôpital Edouard Herriot

OTHER

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sami Hakim, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Jean-Marc Regimbeau, Pr

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Lionel Rebibo, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Bichat, Paris

Jean-Christophe Duchmann, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Compiègne

Jonathan Levy, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique des Cèdres Chât Alliez, Cornebarrieu

Jean-François Bourgaux, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nimes

Ion Donici, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nimes

Vincent Quentin, MD

Role: PRINCIPAL_INVESTIGATOR

CH Saint Brieux

Fabien Fumex, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Jean Mermoz, Lyon

Gaetan Singier, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Jean Mermoz, Lyon

Cécile Gomercic, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Antonio Iannelli, MD

Role: PRINCIPAL_INVESTIGATOR

CHU NICE

Claire Blanchard, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Timothée Wallenhorst, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Damien Bergeat, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Davide Mazza, MD

Role: PRINCIPAL_INVESTIGATOR

CH TOULON

Stéphane Koch, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Besançon

Nicolas Bouviez, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Besançon

Antoine Soprani, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Paris-Bercy

Clément Subtil, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Ulriikka Chaput, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Saint Antoine, Paris

Jérome Rivory, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot - Lyon

Maud Robert, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Edouard Herriot - Lyon

Franck Cholet, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brest

Jérémie Thereaux, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brest

Jean-Christophe Valats, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, France

Countries

France

Other Identifiers

PI2018_843_0017

Identifier Type: -

Identifier Source: org_study_id