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

NCT07295236 | Recruiting DMC

• 1 other identifier: 9947/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagojejunal Anastomotic Leak

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mortality rate

  Mortality rate associated with endoscopic vacuum therapy

  90 days after last endo-vac placement

Secondary Outcomes (3)

• Morbidity rate

  90 days after last endoscopic vacuum placement

• Time from AL diagnosis to discharge

  The number of days from from AL diagnosis to discharge

• Patients satisfactory rate

  90 days after discharge, 365 days after discharge, 2/3/4/5 years after discharge

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Clinical Oncology: lead

Study Sites (1)

National Cancer Institute

Kyiv, 03022, Ukraine

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Oleksii Dobrzhanskyi, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oleksii Dobrzhanskyi, MD

CONTACT

+380638760185; alekseydobrzhanskiy@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical oncoligist

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2035
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

UA (1)