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

Ukrainian Society of Clinical Oncology

Status: Enrolling

Conditions: Esophagojejunal Anastomotic Leak

Study type: Observational

Funder types: Other

Identifiers

NCT07295236

9947/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Endo-vac cohort

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.