Endoscopy for Post-operative Fistula

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2025-03-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-operative Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No