Endoscopy for Post-operative Fistula

Post-operative Fistula Clinical Trial

— FISTULENDO  

Official title:

Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446208
• Other study ID #: SFED N 146
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: June 2024
• Source: French Society of Digestive Endoscopy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Fistula
• Post-operative Fistula

Intervention

Procedure:
• Endoscopy
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.

Locations

Country	Name	City	State
France	Saint Antoine Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Aymeric Becq

Country where clinical trial is conducted

France, 

Outcome

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