Omentectomy vs Omental Preservation in Resectable Cancer

February 16, 2023 updated by: Sandra Montmany-Vioque, Corporacion Parc Tauli

Non-inferiority Randomized Clinical Trial Comparing Omenectomy and Omental Preservation in Resectable Gastric Cancer

European clinical guidelines do not establish a clear recommendation neither for nor against omentectomy of this segment, the American clinical guidelines recommend omentectomy in view of its potential long-term oncological benefit, and Japanese clinical guidelines only recommend 2nd segment omentectomy in locally advanced gastric cancers (stage T3-T4) recommending omental preservation in early gastric cancers (stage T1-T2).

Faced with this lack of consensus, we propose a randomized, prospective and multicentric study in patients with resectable gastric cancer in stage T3-4 N+/- M0. Patients will be randomized into two groups, one where omentectomy of the 2nd omental portion will be performed and another where omental preservation will be performed.

The aim of our study is to analyze the disease-free interval and survival between both groups, also comparing postoperative complications and mortality.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

569

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 18 years old
  • Resectable gastric cancer
  • Gastric cancer T3-4 N+/- M0

Exclusion Criteria:

  • M1
  • Non surgical patients for medical status
  • Non resectable gastric cancer during surgery
  • Endoscopic resectable gastric cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Omentectomy
Omentectomy during cancer gastric surgery
Other: Surgery procedure
Omentectomy vs omental preservations during gastric surgery
Other Names:
  • Omentectomy
  • Omental preservation
Other: Omental preservation
Preserval omentation during cancer gastric surgery
Other: Surgery procedure
Omentectomy vs omental preservations during gastric surgery
Other Names:
  • Omentectomy
  • Omental preservation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free interval
Time Frame: 5 years
time between surgery and recurrence. Units of measure: months
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global survival
Time Frame: 5 years
survival between surgery and last follow-up date. Units of measure: percentage
5 years
survival at 5 years
Time Frame: 5 years
survival between surgery and 5 years. Units of measure: percentage
5 years
complications - CCI
Time Frame: 30 days after surgery
type of complications and CCI number. Units of measure: enter number between 1 and 100
30 days after surgery
postoperatory mortality
Time Frame: 30 days after surgery
mortality after surgery. Units of measure: percentage
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2024

Primary Completion (Anticipated)

July 1, 2026

Study Completion (Anticipated)

July 1, 2031

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 16, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 16, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMontmany2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer of Stomach

Clinical Trials on Surgery procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe