Endoscopy for Post-operative Fistula
- Conditions
- Post-operative Fistula
- Registration Number
- NCT04446208
- Lead Sponsor
- Aymeric Becq
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method fistula healing 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Saint Antoine Hospital
🇫🇷Paris, France