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

Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique : an Interventional Multicentric and Prospective Study.

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.

Study Overview

• Status: Completed
• Conditions: Fistula; Gastrostomy
• Intervention / Treatment: Procedure: endoscopy

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80000
      • Centre Hospitalier Universitaire d'Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Fistula Healing at week 18	Number of Participants with Healing at week 18	week 18 after endoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Fistula Healing at week 6	Number of Participants with Fistula Healing at week 6	week 6 after endoscopy
Number of Participants with Fistula Healing at week 12	Number of Participants with Fistula Healing at week 12	week 12 after endoscopy
Number of Participants with Fistula delay	Number of Participants with Fistula delay	up to week 18 after endoscopy
Number of Participants with gastric stenosis	Number of Participants with gastric stenosis	up to week 18 after endoscopy
Measure of length of hospital stay	Average total length of hospital stay	up to week 18 after endoscopy

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: University Hospital, Montpellier; University Hospital, Bordeaux; Saint Antoine University Hospital; Centre Hospitalier Universitaire de Nice; Centre Hospitalier Universitaire de Nīmes; Centre Hospitalier Universitaire de Besancon; University Hospital, Brest; Rennes University Hospital; Nantes University Hospital; Hôpital Edouard Herriot; Bichat Hospital; Clinique Paris-Bercy; Centre Hospitalier de Saint-Brieuc; Hospital Prive Jean Mermoz; Centre Hospitalier de Compiègne; clinique des cedres, Cornebarrieu; Centre Hospitalier Toulon
• Investigators: Principal Investigator: Sami Hakim, MD, CHU Amiens; Principal Investigator: Lionel Rebibo, MD, Hopital Bichat, Paris; Principal Investigator: Jean-Christophe Duchmann, MD, Centre Hospitalier Compiegne; Principal Investigator: Jonathan Levy, MD, Clinique des Cèdres Chât Alliez, Cornebarrieu; Principal Investigator: Jean-François Bourgaux, MD, CHRU Nîmes; Principal Investigator: Ion Donici, MD, CHRU Nîmes; 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, CHU Nantes; 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, CHU 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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: endoscopy; fistula; sleeve gastrostomy; double pig tail stents
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Fistula
• Other Study ID Numbers: PI2018_843_0017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No