Impact of Endo-vac Therapy for Esophago-jejunal Anastomot... | NCT07295236

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

NCT07295236

Sponsor

Ukrainian Society of Clinical Oncology

Status

Recruiting

Last Update Posted

Dec 29, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Esophagojejunal Anastomotic Leak

Interventions

Not provided

Countries

Ukraine

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2025Actual

Primary Completion Date

Dec 1, 2030Estimated

Completion Date

Dec 1, 2035Estimated

First Submitted Date

Dec 7, 2025

First Submission Date that Met QC Criteria

Dec 7, 2025

First Posted Date

Dec 19, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 21, 2025

Last Update Posted Date

Dec 29, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oleksii Dobrzhanskiy, Surgical oncoligist, Ukrainian Society of Clinical OncologyPrincipal Investigator

Lead Sponsor

Ukrainian Society of Clinical OncologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Morbidity rate	Rate of complications associated with endoscopic vacuum therapy or ineffective local control	90 days after last endoscopic vacuum placement
Time from AL diagnosis to discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Study population involves ukrainian patients who developed esophago-jejunal anastomotic leak after total gastrectomy due to gastric cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oleksii Dobrzhanskyi, MD	Contact	+380638760185		alekseydobrzhanskiy@gmail.com

Overall Officials

Name	Affiliation	Role
Oleksii Dobrzhanskyi, MD	National Cancer Institute (NCI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Institute	Recruiting	Kyiv		03022	Ukraine

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymous IPD will be shared upon reasonable request

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided