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| Name | Class |
|---|---|
| Bichat Hospital | OTHER |
| Centre Hospitalier Intercommunal de Compiègne-Noyon | OTHER_GOV |
| clinique des cedres, Cornebarrieu | UNKNOWN |
| Centre Hospitalier Universitaire de Nīmes |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Fistula Healing at week 18 | Number of Participants with Healing at week 18 | week 18 after endoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Fistula Healing at week 6 | Number of Participants with Fistula Healing at week 6 | week 6 after endoscopy |
| Number of Participants with Fistula Healing at week 12 | Number of Participants with Fistula Healing at week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sami Hakim, MD | CHU Amiens | Principal Investigator |
| Jean-Marc Regimbeau, Pr | CHU Amiens | Principal Investigator |
| Lionel Rebibo, MD | Bichat Hospital | Principal Investigator |
| Jean-Christophe Duchmann, MD | Centre Hospitalier Intercommunal de Compiègne-Noyon | Principal Investigator |
| Jonathan Levy, MD | Clinique des Cèdres Chât Alliez, Cornebarrieu | Principal Investigator |
| Jean-François Bourgaux, MD | CHRU Nimes | Principal Investigator |
| Ion Donici, MD | CHRU Nimes | Principal Investigator |
| Vincent Quentin, MD | CH Saint Brieux | Principal Investigator |
| Fabien Fumex, MD | Hopital Jean Mermoz, Lyon | Principal Investigator |
| Gaetan Singier, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Amiens | Amiens | Picardie | 80000 | France |
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| ID | Term |
|---|---|
| D005402 | Fistula |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| OTHER |
| Centre Hospitalier de Saint-Brieuc | OTHER |
| Hospital Prive Jean Mermoz | OTHER |
| Centre Hospitalier Universitaire de Nice | OTHER |
| Nantes University Hospital | OTHER |
| Rennes University Hospital | OTHER |
| Centre Hospitalier Toulon | UNKNOWN |
| Centre Hospitalier Universitaire de Besancon | OTHER |
| Clinique Paris-Bercy | OTHER |
| University Hospital, Bordeaux | OTHER |
| Saint Antoine University Hospital | OTHER |
| Hôpital Edouard Herriot | OTHER |
| University Hospital, Brest | OTHER |
| University Hospital, Montpellier | OTHER |
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|
| week 12 after endoscopy |
| Number of Participants with Fistula delay | Number of Participants with Fistula delay | up to week 18 after endoscopy |
| Number of Participants with gastric stenosis | Number of Participants with gastric stenosis | up to week 18 after endoscopy |
| Measure of length of hospital stay | Average total length of hospital stay | up to week 18 after endoscopy |
| Hopital Jean Mermoz, Lyon |
| Principal Investigator |
| Cécile Gomercic, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Antonio Iannelli, MD | Centre Hospitalier Universitaire de Nice | Principal Investigator |
| Claire Blanchard, MD | Nantes University Hospital | Principal Investigator |
| Timothée Wallenhorst, MD | Rennes University Hospital | Principal Investigator |
| Damien Bergeat, MD | Rennes University Hospital | Principal Investigator |
| Davide Mazza, MD | CH TOULON | Principal Investigator |
| Stéphane Koch, MD | CHRU Besançon | Principal Investigator |
| Nicolas Bouviez, MD | CHRU Besançon | Principal Investigator |
| Antoine Soprani, MD | Clinique Paris-Bercy | Principal Investigator |
| Clément Subtil, MD | University Hospital, Bordeaux | Principal Investigator |
| Ulriikka Chaput, MD | Hopital Saint Antoine, Paris | Principal Investigator |
| Jérome Rivory, MD | Hopital Edouard Herriot - Lyon | Principal Investigator |
| Maud Robert, MD | Hopital Edouard Herriot - Lyon | Principal Investigator |
| Franck Cholet, MD | CHU Brest | Principal Investigator |
| Jérémie Thereaux, MD | CHU Brest | Principal Investigator |
| Jean-Christophe Valats, MD | University Hospital, Montpellier | Principal Investigator |
| D013514 | Surgical Procedures, Operative |