Post-operative FistulaFISTULENDONCT04446208
Endoscopy for Post-operative Fistula
An observational study of Post-operative Fistula, run by Aymeric Becq at 1 site in France.
Trial summary
Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Fistula
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 5 Mar 2025
- Phase
- Observational
- 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
Study population: Patients with post-operative fistula of the upper digestive tract, in the setting of a cancerous underlying condition.
Who may be able to join
- Patient over 18 years
- Early fistula (< 30 days)
- Post surgery: Lewis Santy, Akiyama, partial or total gastrectomy
- Indication of endoscopic management: metal stents and/or plastic stents
Who cannot join
- Pregnancy
- Incapable of decision making and informed consent
- Life expectancy < 1 month
- General anesthesia contra-indication
- Late fistula (> 30 days)
- Prior endoscopic treatment
Show all 9Show fewer
- Wall ischemia
- Duodenum or small bowel fistula
- Post bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract
Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.
- Conditions
- Post-operative Fistula
- Being tested
- Endoscopy
- Keywords
- Fistula, Upper digestive tract, Cancer
- Medical subject headings
- Fistula, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Endoscopic treatment will consist in placement of a metal stent in a patient with early fistula (< 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small.
What is being measured
The primary outcome is the main question the study is designed to answer.
fistula healing
The main outcome is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.
Measured: 3 months after the end of the endoscopic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start1 Jul 2021
- Primary completion1 Jul 2024
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative FistulaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymeric Becq
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aymeric Becq, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446208
- Sponsor's protocol ID
- SFED N 146
- Acronym
- FISTULENDO
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2020
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract
- ClinicalTrials.gov ID
- NCT04446208
- Acronym / sponsor ID
- FISTULENDO / SFED N 146
- Conditions
- Post-operative Fistula
- Keywords
- Fistula, Upper digestive tract, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Aymeric BecqUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 24 Jun 2020 (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.
Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with post-operative fistula of the upper digestive tract, in the setting of a cancerous underlying condition.
Key inclusion criteria (4 listed)
- Patient over 18 years
- Early fistula (< 30 days)
- Post surgery: Lewis Santy, Akiyama, partial or total gastrectomy
- Indication of endoscopic management: metal stents and/or plastic stents
Key exclusion criteria (9 listed)
- Pregnancy
- Incapable of decision making and informed consent
- Life expectancy < 1 month
- General anesthesia contra-indication
- Late fistula (> 30 days)
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 |
|---|---|---|
| EndoscopyEndoscopic treatment will consist in placement of a metal stent in a patient with early fistula (< 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small. | Procedure or surgery | – |
Primary outcome
fistula healing
Time frame: 3 months after the end of the endoscopic
The main outcome is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.
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 6 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Fistula, run by Aymeric Becq 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 4 inclusion and 9 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 6 Aug 2025. 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?
fistula healing (time frame: 3 months after the end of the endoscopic). 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 6 Aug 2025.