Endoscopy for Post-operative Fistula (FISTULENDO)

August 20, 2021 updated by: Aymeric Becq

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75012
        • Recruiting
        • Saint Antoine Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with post-operative fistula of the upper digestive tract, in the setting of a cancerous underlying condition.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnancy
  • Incapable of decision making and informed consent
  • Life expectancy < 1 month
  • General anesthesia contra-indication
  • Late fistula (> 30 days)
  • Prior endoscopic treatment
  • Wall ischemia
  • Duodenum or small bowel fistula
  • Post bariatric surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months after the end of the endoscopic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aymeric Becq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

June 22, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFED N 146

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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