Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique (bartoli)
Primary Purpose
Gastrostomy, Fistula
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
endoscopy
Sponsored by
About this trial
This is an interventional treatment trial for Gastrostomy focused on measuring sleeve gastrostomy, endoscopy, fistula, double pig tail stents
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
Sites / Locations
- Centre Hospitalier Universitaire d'Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
endoscopy
Arm 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.
Outcomes
Primary Outcome Measures
Number of Participants with Fistula Healing at week 18
Number of Participants with Healing at week 18
Secondary Outcome Measures
Number of Participants with Fistula Healing at week 6
Number of Participants with Fistula Healing at week 6
Number of Participants with Fistula Healing at week 12
Number of Participants with Fistula Healing at week 12
Number of Participants with Fistula delay
Number of Participants with Fistula delay
Number of Participants with gastric stenosis
Number of Participants with gastric stenosis
Measure of length of hospital stay
Average total length of hospital stay
Full Information
NCT ID
NCT04049955
First Posted
July 18, 2019
Last Updated
January 17, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT04049955
Brief Title
Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
November 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrostomy, Fistula
Keywords
sleeve gastrostomy, endoscopy, fistula, double pig tail stents
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
endoscopy
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
endoscopy
Intervention 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.
Primary Outcome Measure Information:
Title
Number of Participants with Fistula Healing at week 18
Description
Number of Participants with Healing at week 18
Time Frame
week 18 after endoscopy
Secondary Outcome Measure Information:
Title
Number of Participants with Fistula Healing at week 6
Description
Number of Participants with Fistula Healing at week 6
Time Frame
week 6 after endoscopy
Title
Number of Participants with Fistula Healing at week 12
Description
Number of Participants with Fistula Healing at week 12
Time Frame
week 12 after endoscopy
Title
Number of Participants with Fistula delay
Description
Number of Participants with Fistula delay
Time Frame
up to week 18 after endoscopy
Title
Number of Participants with gastric stenosis
Description
Number of Participants with gastric stenosis
Time Frame
up to week 18 after endoscopy
Title
Measure of length of hospital stay
Description
Average total length of hospital stay
Time Frame
up to week 18 after endoscopy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sami Hakim, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Marc Regimbeau, Pr
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lionel Rebibo, MD
Organizational Affiliation
Hopital Bichat, Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Duchmann, MD
Organizational Affiliation
Centre Hospitalier Compiègne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Levy, MD
Organizational Affiliation
Clinique des Cèdres Chât Alliez, Cornebarrieu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-François Bourgaux, MD
Organizational Affiliation
CHRU Nimes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ion Donici, MD
Organizational Affiliation
CHRU Nimes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Quentin, MD
Organizational Affiliation
CH Saint Brieux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabien Fumex, MD
Organizational Affiliation
Hopital Jean Mermoz, Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gaetan Singier, MD
Organizational Affiliation
Hopital Jean Mermoz, Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cécile Gomercic, MD
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antonio Iannelli, MD
Organizational Affiliation
CHU Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire Blanchard, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothée Wallenhorst, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Damien Bergeat, MD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Davide Mazza, MD
Organizational Affiliation
CH TOULON
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stéphane Koch, MD
Organizational Affiliation
CHRU Besançon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Bouviez, MD
Organizational Affiliation
CHRU Besançon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine Soprani, MD
Organizational Affiliation
Clinique Paris-Bercy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clément Subtil, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulriikka Chaput, MD
Organizational Affiliation
Hopital Saint Antoine, Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérome Rivory, MD
Organizational Affiliation
Hopital Edouard Herriot - Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maud Robert, MD
Organizational Affiliation
Hopital Edouard Herriot - Lyon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Franck Cholet, MD
Organizational Affiliation
CHU Brest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jérémie Thereaux, MD
Organizational Affiliation
CHU Brest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Valats, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique
We'll reach out to this number within 24 hrs