Endoscopy for Post-operative Fistula

NCT04446208 | Completed

• 1 other identifier: SFED N 146
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Fistula

Keywords

Fistula; Upper digestive tract; Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Endoscopy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with post-operative fistula of the upper digestive tract, in the setting of a cancerous underlying condition.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aymeric Becq: lead

Study Sites (1)

Saint Antoine Hospital

Paris, 75012, France

Location

MeSH Terms

Conditions

Fistula; Neoplasms

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor-principal Investigator

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 24, 2020
• Study Start: July 1, 2021
• Primary Completion: July 1, 2024
• Study Completion: March 5, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

FR (1)