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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2024
Source French Society of Digestive Endoscopy
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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