Endoscopic treatment for post-operative fistula in cancer patients
Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract
This study tests if a special endoscopic treatment can help cancer patients with esophageal or gastric issues heal from fistulas that develop after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | French Society of Digestive Endoscopy Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04446208 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of endoscopic management for early post-operative fistulas in patients with esophageal or gastric cancer. Conducted in tertiary centers in France, the study focuses on patients who have undergone specific surgical procedures and are experiencing fistulas within 30 days post-surgery. The primary outcome is the healing of the fistula, assessed through CT scans three months after treatment. The study aims to fill the gap in data regarding the success of this standard care approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with early post-operative fistulas following specific gastric surgeries.
Not a fit: Patients with late fistulas, those who have undergone prior endoscopic treatment, or those with contraindications to general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve healing rates for patients suffering from post-operative fistulas, enhancing their recovery and quality of life.
How similar studies have performed: While endoscopic treatment for post-operative fistulas is becoming standard care, this study aims to provide specific data on its effectiveness, indicating a need for further evaluation in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Saint Antoine Hospital — Paris, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.