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Endoscopy for Post-operative Fistula

NCT04446208 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2025-08-06

No results posted yet for this study

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. 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

Interventions

PROCEDURE

Endoscopy

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.

Sponsors & Collaborators

  • Aymeric Becq

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2024-07-01
Completion
2025-03-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04446208 on ClinicalTrials.gov