Endoscopy for Post-operative Fistula (FISTULENDO)

Aymeric Becq

Status: Completed

Conditions: Post-operative Fistula

Treatments: Procedure: Endoscopy

Study type: Observational

Funder types: Other

Identifiers

NCT04446208

SFED N 146

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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