Impact of Endo-vac Therapy for Esophago-jejunal Anastomotic Leak (ENDO-VAL)

December 21, 2025 updated by: Oleksii Dobrzhanskiy, Ukrainian Society of Clinical Oncology

Prospective Observational Study on Endo-vac Therapy for Esophago-jejunal Anastomotic Leak

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ukraine
      • Kyiv, Ukraine, 03022
        • Recruiting
        • National Cancer Institute
        • Contact:
        • Sub-Investigator:
          • Yurii Kondratskyi, MD, PhD
        • Sub-Investigator:
          • Mykyta Pepenin, MD
        • Sub-Investigator:
          • Andrii Horodetskyi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population involves ukrainian patients who developed esophago-jejunal anastomotic leak after total gastrectomy due to gastric cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endo-vac cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality rate
Time Frame: 90 days after last endo-vac placement
Mortality rate associated with endoscopic vacuum therapy
90 days after last endo-vac placement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity rate
Time Frame: 90 days after last endoscopic vacuum placement
Rate of complications associated with endoscopic vacuum therapy or ineffective local control
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
time from AL diagnosis to discharge
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
Patients satisfactory rate assessed by quality of life questionnaires and patient-reported outcomes scales
90 days after discharge, 365 days after discharge, 2/3/4/5 years after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ukrainian Society of Clinical Oncology

Investigators

  • Principal Investigator: Oleksii Dobrzhanskyi, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2035

Study Registration Dates

First Submitted

December 7, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 19, 2025

Study Record Updates

Last Update Posted (Actual)

December 29, 2025

Last Update Submitted That Met QC Criteria

December 21, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9947/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymous IPD will be shared upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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