Impact of Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Esophagojejunal Anastomotic Leak. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ukraine
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study on Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
Overview
The goal of this observational study is to assess the impact of endoscopic vacuum therapy in patients who underwent total gastrectomy due to gastric cancer and developed esophago-jejunal anastomotic leakage. The main outcomes to be investigated are the following: Primary endpoint: mortality rate Secondary endpoints: morbidity rate, time from AL diagnosis to discharge, patients satisfactory rate.
Detailed description
Patients who are diagnosed with asophago-jejunal anastomotic leakage will undergo endoscopic vacuum therapy. Local source control may be additionally achieved with para-anastomotic drains.
Primary outcome measures
- Mortality rate [Time frame: 90 days after last endo-vac placement]
Secondary outcome measures (3)
- Morbidity rate [Time frame: 90 days after last endoscopic vacuum placement]
- Time from AL diagnosis to discharge [Time frame: The number of days from from AL diagnosis to discharge]
- Patients satisfactory rate [Time frame: 90 days after discharge, 365 days after discharge, 2/3/4/5 years after discharge]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ukraine · 1 center
- National Cancer Institute — Kyiv
Identifiers
NCT: NCT07295236 · 9947/2025