Endoscopy for Post-operative Fistula

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.

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Key information

Conditions

Post-operative Fistula Fistula Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Antoine Hospital

Paris, 75012, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopy

Procedure

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.

Primary outcomes

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.

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Sponsors and collaborators

Lead sponsor

Aymeric Becq

Other

Registry information

Official study title

Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract

Acronym: FISTULENDO

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2025
First posted: Jun 24, 2020
Registry last updated: Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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