Fistula, Gastrostomy
Conditions
Keywords
sleeve gastrostomy, endoscopy, fistula, double pig tail stents
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.
Interventions
PROCEDUREendoscopy
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.
Sponsors
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
Centre Hospitalier Universitaire, Amiens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Fistula Healing at week 18 | week 18 after endoscopy | Number of Participants with Healing at week 18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Fistula Healing at week 6 | week 6 after endoscopy | Number of Participants with Fistula Healing at week 6 |
| Number of Participants with Fistula Healing at week 12 | week 12 after endoscopy | Number of Participants with Fistula Healing at week 12 |
| Number of Participants with Fistula delay | up to week 18 after endoscopy | Number of Participants with Fistula delay |
| Number of Participants with gastric stenosis | up to week 18 after endoscopy | Number of Participants with gastric stenosis |
| Measure of length of hospital stay | up to week 18 after endoscopy | Average total length of hospital stay |
Countries
France
Outcome results
None listed