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

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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

Source Centre Hospitalier Universitaire, Amiens
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.

Overall Status Not yet recruiting
Start Date August 2019
Completion Date November 2021
Primary Completion Date July 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants with Fistula Healing at week 18 week 18 after endoscopy
Secondary Outcome
Measure Time Frame
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
Enrollment 150
Condition
Intervention

Intervention Type: Procedure

Intervention Name: endoscopy

Description: 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.

Arm Group Label: endoscopy

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Sami Hakim, MD

Phone: (33)322088847

Email: [email protected]

Verification Date

August 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: endoscopy

Type: Experimental

Description: 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.

Acronym bartoli
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov