Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- fistula healing
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Aymeric Becq
Medical doctor-principal Investigator
French Society of Digestive Endoscopy