Endoscopic vacuum (Endo-VAC) treatment for leaks after total gastrectomy
Official title: Prospective Observational Study on Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
Run by Ukrainian Society of Clinical Oncology · NCT07295236 · Data updated 2026-11-12
This study will try endoscopic vacuum therapy (Endo-VAC) to treat esophago-jejunal anastomotic leaks in patients who had total gastrectomy for gastric cancer and are clinically stable without need for diversion surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Ukrainian Society of Clinical Oncology Academic / other |
| Locations | 1 site (Kyiv) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | December 1, 2030 |
| Study ends | December 1, 2035 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT07295236 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who underwent total gastrectomy for gastric cancer, developed an esophago-jejunal leak involving ≤50% of the anastomotic circumference, and are hemodynamically stable without indications for diversion surgery.
✕Probably not a fit
Patients who are hemodynamically unstable, have leaks involving >50% of the anastomotic circumference, or decline endoscopic vacuum therapy are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Patients who develop an esophago-jejunal anastomotic leak after total gastrectomy for gastric cancer and meet inclusion criteria will receive endoscopic vacuum therapy, with para-anastomotic drains used as needed for local source control. The observational protocol records outcomes including mortality (primary endpoint), morbidity, time from leak diagnosis to hospital discharge, and patient satisfaction. There is no randomized comparator and treatment reflects current clinical practice at the National Cancer Institute in Kyiv. Data are collected prospectively to describe clinical course and outcomes following Endo-VAC management.
Why it matters
Potential benefit: If successful, endoscopic vacuum therapy could reduce deaths and complications and shorten hospital stays compared with more invasive surgical options.
How similar studies have gone: Endoscopic vacuum therapy has been reported in multiple case series and cohort studies to be effective for esophageal and anastomotic leaks, although randomized controlled data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients who developed esophago-jejunal anastomotic leak less than 50% of circumference of anastomosis * patients who developed esophago-jejunal anastomotic leak and remained stable at the moment of diagnosis with no indications for diversion surgery Exclusion Criteria: * unstable patients who developed esophago-jejunal anastomotic leak * patients who developed esophago-jejunal anastomotic leak more than 50% or anastomotic circumference * patients who rejected endoscopic vacuum therapy
Where it's running
-
National Cancer Institute
Kyiv, Ukraine Recruiting
Study contacts
- Principal investigator: Oleksii Dobrzhanskyi, MD — National Cancer Institute (NCI)
- Study coordinator: Oleksii Dobrzhanskyi, MD
- Email: alekseydobrzhanskiy@gmail.com
- Phone: +380638760185
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.