Clinical trial NCT04049955: Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique
Official title: Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique : an Interventional Multicentric and Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrostomy
Fistula
Keywords: sleeve gastrostomy
endoscopy
fistula
double pig tail stents
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Bichat Hospital
name: centre hospitalier de Compiegne
name: clinique des cedres, Cornebarrieu
name: Centre Hospitalier Universitaire de Nīmes
name: Centre Hospitalier de Saint-Brieuc
name: Hospital Prive Jean Mermoz
name: Centre Hospitalier Universitaire de Nice
name: Nantes University Hospital
name: Rennes University Hospital
name: Centre Hospitalier Toulon
name: Centre Hospitalier Universitaire de Besancon
name: Clinique Paris-Bercy
name: University Hospital, Bordeaux
name: Saint Antoine University Hospital
name: Hôpital Edouard Herriot
name: University Hospital, Brest
name: University Hospital, Montpellier
First posted: 2019-08-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Fistula Healing at week 18
timeFrame: week 18 after endoscopy
Secondary outcomes:
measure: Number of Participants with Fistula Healing at week 6
timeFrame: week 6 after endoscopy
measure: Number of Participants with Fistula Healing at week 12
timeFrame: week 12 after endoscopy
measure: Number of Participants with Fistula delay
timeFrame: up to week 18 after endoscopy
measure: Number of Participants with gastric stenosis
timeFrame: up to week 18 after endoscopy
measure: Measure of length of hospital stay
timeFrame: up to week 18 after endoscopy
Other outcomes:
Locations:
city: Amiens
country: France
facility: Centre Hospitalier Universitaire d'Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens
name: Sami Hakim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Jean-Marc Regimbeau, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Bichat, Paris
name: Lionel Rebibo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Compiègne
name: Jean-Christophe Duchmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique des Cèdres Chât Alliez, Cornebarrieu
name: Jonathan Levy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Nimes
name: Jean-François Bourgaux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Nimes
name: Ion Donici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH Saint Brieux
name: Vincent Quentin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Jean Mermoz, Lyon
name: Fabien Fumex, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Jean Mermoz, Lyon
name: Gaetan Singier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NICE
name: Cécile Gomercic, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU NICE
name: Antonio Iannelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Claire Blanchard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Timothée Wallenhorst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Damien Bergeat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH TOULON
name: Davide Mazza, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Stéphane Koch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Besançon
name: Nicolas Bouviez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Paris-Bercy
name: Antoine Soprani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Clément Subtil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Saint Antoine, Paris
name: Ulriikka Chaput, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Edouard Herriot - Lyon
name: Jérome Rivory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Edouard Herriot - Lyon
name: Maud Robert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brest
name: Franck Cholet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brest
name: Jérémie Thereaux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: Jean-Christophe Valats, MD
role: PRINCIPAL_INVESTIGATOR
References: