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NCT Number: NCT07295236

Impact of 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.

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Key information

Conditions

Esophagojejunal Anastomotic Leak Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Institute

Kyiv, 03022, Ukraine

Location status: Recruiting

Location contact

Andrii Horodetskyi, MD

SUB_INVESTIGATOR

Mykyta Pepenin, MD

SUB_INVESTIGATOR

Oleksii Dobrzhanskyi

CONTACT

[email protected]

+380638760185

Yurii Kondratskyi, MD, PhD

SUB_INVESTIGATOR

About this study

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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality rate

    Time frame: 90 days after last endo-vac placement

    Mortality rate associated with endoscopic vacuum therapy

Secondary outcomes

  1. Morbidity rate

    Time frame: 90 days after last endoscopic vacuum placement

    Rate of complications associated with endoscopic vacuum therapy or ineffective local control

  2. Time from AL diagnosis to discharge

    Time frame: The number of days from from AL diagnosis to discharge

    time from AL diagnosis to discharge

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Oleksii Dobrzhanskyi, MD

CONTACT

[email protected]

+380638760185

Sponsors and collaborators

Lead sponsor

Ukrainian Society of Clinical Oncology

Other

Registry information

Official study title

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

Acronym: ENDO-VAL

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Dec 19, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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