Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial
Keywani, K; Eshuis, W J; Borgstein, A B J; van Det, M J; van Duijvendijk, P; van Etten, B; Grimminger, P P; Heisterkamp, J; Lagarde, S M; Luyer, M D P; Markar, S R; Meijer, S L; Pierie, J P E N; Roviello, F; Ruurda, J P; van Sandick, J W; Sosef, M; Witteman, B P L; de Steur, W O; Lissenberg-Witte, B I; van Berge Henegouwen, M I; Gisbertz, S S
(2024) Trials, volume 25, issue 1
(Article)
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
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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 6th January 2022.
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Keywords: Adult, Aged, Disease-Free Survival, Equivalence Trials as Topic, Female, Gastrectomy/adverse effects, Humans, Lymph Node Excision/adverse effects, Male, Middle Aged, Multicenter Studies as Topic, Omentum/surgery, Organ Sparing Treatments/methods, Quality of Life, Randomized Controlled Trials as Topic, Stomach Neoplasms/surgery, Time Factors, Treatment Outcome, Journal Article
ISSN: 1745-6215
Publisher: BioMed Central
Note: Publisher Copyright: © The Author(s) 2024.
(Peer reviewed)