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Completed

NCT Number: NCT04049955

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire d'Amiens

Amiens, Picardie, 80000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopy

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.

Primary outcomes

  1. Number of Participants with Fistula Healing at week 18

    Time frame: week 18 after endoscopy

    Number of Participants with Healing at week 18

Secondary outcomes

  1. Number of Participants with Fistula Healing at week 6

    Time frame: week 6 after endoscopy

    Number of Participants with Fistula Healing at week 6

  2. Number of Participants with Fistula Healing at week 12

    Time frame: week 12 after endoscopy

    Number of Participants with Fistula Healing at week 12

  3. Number of Participants with Fistula delay

    Time frame: up to week 18 after endoscopy

    Number of Participants with Fistula delay

  4. Number of Participants with gastric stenosis

    Time frame: up to week 18 after endoscopy

    Number of Participants with gastric stenosis

  5. Measure of length of hospital stay

    Time frame: up to week 18 after endoscopy

    Average total length of hospital stay

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Collaborators

  • Bichat Hospital
  • Centre Hospitalier Intercommunal de Compiègne-Noyon
  • Centre Hospitalier Toulon
  • Centre Hospitalier Universitaire de Besancon
  • Centre Hospitalier Universitaire de Nice
  • Centre Hospitalier Universitaire de Nīmes
  • Centre Hospitalier de Saint-Brieuc
  • Clinique Paris-Bercy
  • Hospital Prive Jean Mermoz
  • Hôpital Edouard Herriot
  • Nantes University Hospital
  • Rennes University Hospital
  • Saint Antoine University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Brest
  • University Hospital, Montpellier
  • clinique des cedres, Cornebarrieu

Registry information

Official study title

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

Acronym: bartoli

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 8, 2019
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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