Esophagojejunal Anastomotic LeakENDO-VALNCT07295236
Impact of Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
An observational study of Esophagojejunal Anastomotic Leak, run by Ukrainian Society of Clinical Oncology at 1 site in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophagojejunal Anastomotic Leak
- How many people
- 100 participants
- Where
- 1 siteUkraine
- Study dates
- 1 Dec 2025to 1 Dec 2035
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population involves ukrainian patients who developed esophago-jejunal anastomotic leak after total gastrectomy due to gastric cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site, 1 recruiting
- Recruiting
National Cancer Institute
Kyiv, 03022
Oleksii Dobrzhanskyi, +380638760185, alekseydobrzhanskiy@gmail.com
Yurii Kondratskyi, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophagojejunal Anastomotic Leak
- Keywords
- gastric cancer, esophagojejunal anastomotic leak, total gastrectomy, Endoscopic vacuum therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Mortality rate associated with endoscopic vacuum therapy
Measured: 90 days after last endo-vac placement
Secondary outcomes (3)
Morbidity rate
Rate of complications associated with endoscopic vacuum therapy or ineffective local control
Measured: 90 days after last endoscopic vacuum placement
Time from AL diagnosis to discharge
time from AL diagnosis to discharge
Measured: The number of days from from AL diagnosis to discharge
Patients satisfactory rate
Patients satisfactory rate assessed by quality of life questionnaires and patient-reported outcomes scales
Measured: 90 days after discharge, 365 days after discharge, 2/3/4/5 years after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagojejunal Anastomotic LeakStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Clinical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oleksii Dobrzhanskiy, Ukrainian Society of Clinical Oncology
- Investigators
- Oleksii Dobrzhanskyi, MD, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07295236
- Sponsor's protocol ID
- 9947/2025
- Acronym
- ENDO-VAL
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous IPD will be shared upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Endo-vac Therapy for Esophago-jejunal Anastomotic Leak
- ClinicalTrials.gov ID
- NCT07295236
- Acronym / sponsor ID
- ENDO-VAL / 9947/2025
- Conditions
- Esophagojejunal Anastomotic Leak
- Keywords
- gastric cancer, esophagojejunal anastomotic leak, total gastrectomy, Endoscopic vacuum therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ukrainian Society of Clinical OncologyUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2035 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population involves ukrainian patients who developed esophago-jejunal anastomotic leak after total gastrectomy due to gastric cancer
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality rate
Time frame: 90 days after last endo-vac placement
Mortality rate associated with endoscopic vacuum therapy
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymous IPD will be shared upon reasonable request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oleksii Dobrzhanskyi, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagojejunal Anastomotic Leak, run by Ukrainian Society of Clinical Oncology at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oleksii Dobrzhanskyi, MD (+380638760185, alekseydobrzhanskiy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 90 days after last endo-vac placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.