Post-operative Fistula Clinical Trial
— FISTULENDOOfficial title:
Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract
NCT number | NCT04446208 |
Other study ID # | SFED N 146 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | August 2024 |
Verified date | June 2024 |
Source | French Society of Digestive Endoscopy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | August 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Saint Antoine Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Aymeric Becq |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fistula healing | 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. | 3 months after the end of the endoscopic |