Omentum Preservation Versus Complete Omentectomy in Gastrectomy for Gastric Cancer (OMEGA Trial): Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2024 Sep 5

PMID 39232781

Authors

K Keywani

W J Eshuis

A B J Borgstein

M J van Det

P van Duijvendijk

B van Etten

P P Grimminger

J Heisterkamp

S M Lagarde

M D P Luyer

S R Markar

S L Meijer

J P E N Pierie

F Roviello

J P Ruurda

J W van Sandick

M Sosef

B P L Witteman

W O de Steur

B I Lissenberg-Witte

M I van Berge Henegouwen

S S Gisbertz

Affiliations

Soon will be listed here.

Abstract

Background: Potentially curative therapy for locally advanced gastric cancer consists of gastrectomy, usually in combination with perioperative chemotherapy. An oncological resection includes a radical (R0) gastrectomy and modified D2 lymphadenectomy; generally, a total omentectomy is also performed, to ensure the removal of possible microscopic disease. However, the omentum functions as a regulator of regional immune responses to prevent infections and prevents adhesions which could lead to bowel obstructions. Evidence supporting a survival benefit of routine complete omentectomy during gastrectomy is lacking.

Methods: OMEGA is a randomized controlled, open, parallel, non-inferiority, multicenter trial. Eligible patients are operable (ASA < 4) and have resectable (≦ cT4aN3bM0) primary gastric cancer. Patients will be 1:1 randomized between (sub)total gastrectomy with omentum preservation distal of the gastroepiploic vessels versus complete omentectomy. For a power of 80%, the target sample size is 654 patients. The primary objective is to investigate whether omentum preservation in gastrectomy for cancer is non-inferior to complete omentectomy in terms of 3-year overall survival. Secondary endpoints include intra- and postoperative outcomes, such as blood loss, operative time, hospital stay, readmission rate, quality of life, disease-free survival, and cost-effectiveness.

Discussion: The OMEGA trial investigates if omentum preservation during gastrectomy for gastric cancer is non-inferior to complete omentectomy in terms of 3-year overall survival, with non-inferiority being determined based on results from both the intention-to-treat and the per-protocol analyses. The OMEGA trial will elucidate whether routine complete omentectomy could be omitted, potentially reducing overtreatment.

Trial Registration: ClinicalTrials.gov NCT05180864. Registered on 6 January 2022.

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