Post-operative Fistula
Conditions
Keywords
Fistula, Upper digestive tract, Cancer
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.
Interventions
PROCEDUREEndoscopy
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.
Sponsors
Aymeric Becq
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Outcome results
None listed