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

Gastrostomy Clinical Trial

— bartoli  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04049955
• Other study ID #: PI2018_843_0017
• Status: Completed
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: November 1, 2021

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Gastrostomy

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire d'Amiens	Amiens	Picardie

Sponsors (18)

Lead Sponsor

Collaborator

Centre Hospitalier Universitaire, Amiens

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Fistula Healing at week 18	Number of Participants with Healing at week 18	week 18 after endoscopy
Secondary	Number of Participants with Fistula Healing at week 6	Number of Participants with Fistula Healing at week 6	week 6 after endoscopy
Secondary	Number of Participants with Fistula Healing at week 12	Number of Participants with Fistula Healing at week 12	week 12 after endoscopy
Secondary	Number of Participants with Fistula delay	Number of Participants with Fistula delay	up to week 18 after endoscopy
Secondary	Number of Participants with gastric stenosis	Number of Participants with gastric stenosis	up to week 18 after endoscopy
Secondary	Measure of length of hospital stay	Average total length of hospital stay	up to week 18 after endoscopy