GastrostomybartoliNCT04049955
Endoscopic Management of Fistulas Related to Sleeve Gastrectomy With Double Pigtail Stents According to the BARTOLI Technique
A study testing endoscopy in people with Gastrostomy and Fistula, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrostomy, Fistula
- What is being tested?
- endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2019to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Gastrostomy, Fistula
- Being tested
- endoscopy
- Keywords
- sleeve gastrostomy, endoscopy, fistula, double pig tail stents
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Fistula Healing at week 18
Number of Participants with Healing at week 18
Measured: week 18 after endoscopy
Secondary outcomes (5)
Number of Participants with Fistula Healing at week 6
Number of Participants with Fistula Healing at week 6
Measured: week 6 after endoscopy
Number of Participants with Fistula Healing at week 12
Number of Participants with Fistula Healing at week 12
Measured: week 12 after endoscopy
Number of Participants with Fistula delay
Number of Participants with Fistula delay
Measured: up to week 18 after endoscopy
Number of Participants with gastric stenosis
Number of Participants with gastric stenosis
Measured: up to week 18 after endoscopy
Measure of length of hospital stay
Average total length of hospital stay
Measured: up to week 18 after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Aug 2019
- Primary completion1 Jul 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrostomyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Bichat Hospital, Centre Hospitalier Intercommunal de Compiègne-Noyon, 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
- Responsible party
- Sponsor
- Investigators
- Sami Hakim, MD, Principal investigator, CHU AmiensJean-Marc Regimbeau, Pr, Principal investigator, CHU AmiensLionel Rebibo, MD, Principal investigator, Bichat HospitalJean-Christophe Duchmann, MD, Principal investigator, Centre Hospitalier Intercommunal de Compiègne-NoyonJonathan Levy, MD, Principal investigator, Clinique des Cèdres Chât Alliez, CornebarrieuJean-François Bourgaux, MD, Principal investigator, CHRU NimesIon Donici, MD, Principal investigator, CHRU NimesVincent Quentin, MD, Principal investigator, CH Saint Brieux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049955
- Sponsor's protocol ID
- PI2018_843_0017
- Acronym
- bartoli
- Status last verified
- Jan 2023
- First submitted
- 18 Jul 2019
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04049955
- Acronym / sponsor ID
- bartoli / PI2018_843_0017
- Conditions
- Gastrostomy, Fistula
- Keywords
- sleeve gastrostomy, endoscopy, fistula, double pig tail stents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Bichat Hospital, Centre Hospitalier Intercommunal de Compiègne-Noyon, 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
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| endoscopy | Experimental | Procedure: endoscopyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopyIn 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. | Procedure or surgery | endoscopy |
Primary outcome
Number of Participants with Fistula Healing at week 18
Time frame: week 18 after endoscopy
Number of Participants with Healing at week 18
5 secondary outcomes
Number of Participants with Fistula Healing at week 6
Time frame: week 6 after endoscopy
Number of Participants with Fistula Healing at week 12
Time frame: week 12 after endoscopy
Number of Participants with Fistula delay
Time frame: up to week 18 after endoscopy
Number of Participants with gastric stenosis
Time frame: up to week 18 after endoscopy
Measure of length of hospital stay
Time frame: up to week 18 after endoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sami Hakim, MD principal investigator
CHU Amiens
Jean-Marc Regimbeau, Pr principal investigator
CHU Amiens
Lionel Rebibo, MD principal investigator
Bichat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopy in people with Gastrostomy and Fistula, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Fistula Healing at week 18 (time frame: week 18 after endoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.