Impact of Endo-vac Therapy for Esophago-jejunal Anastomotic Leak

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07295236

Acronym

ENDO-VAL

Enrollment

100

Registered

2025-12-19

Start date

2025-12-01

Completion date

2035-12-01

Last updated

2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagojejunal Anastomotic Leak

Keywords

gastric cancer, esophagojejunal anastomotic leak, total gastrectomy, Endoscopic vacuum therapy

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Morbidity rate	90 days after last endoscopic vacuum placement	Rate of complications associated with endoscopic vacuum therapy or ineffective local control
Time from AL diagnosis to discharge	The number of days from from AL diagnosis to discharge	time from AL diagnosis to discharge
Patients satisfactory rate	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

Countries

Ukraine

Contacts

Primary ContactOleksii Dobrzhanskyi, MD

alekseydobrzhanskiy@gmail.com+380638760185

Outcome results