CompletedNot Applicable

Endoscopy for Post-operative Fistula

France85 participantsStarted 2021-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

fistula healing

Timeframe: 3 months after the end of the endoscopic

Trial details

NCT IDNCT04446208

SponsorAymeric Becq

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-01

View on ClinicalTrials.gov More Post-operative Fistula trials