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. 2024 Sep 4;25(1):588.
doi: 10.1186/s13063-024-08396-z.

Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial

K Keywani  1   2 , W J Eshuis  1   2 , A B J Borgstein  1   2 , M J van Det  3 , P van Duijvendijk  4 , B van Etten  5 , P P Grimminger  6 , J Heisterkamp  7 , S M Lagarde  8 , M D P Luyer  9 , S R Markar  10 , S L Meijer  11 , J P E N Pierie  12 , F Roviello  13 , J P Ruurda  14 , J W van Sandick  15 , M Sosef  16 , B P L Witteman  17 , W O de Steur  18 , B I Lissenberg-Witte  19 , M I van Berge Henegouwen  1   2 , S S Gisbertz  20   21
Affiliations

Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial

K Keywani et al. Trials. .

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 6th January 2022.

Keywords: Gastric cancer; Omentectomy; Randomized controlled trial; Survival.

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Conflict of interest statement

All authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The schedule of enrollment, interventions, and assessment according to SPIRIT
Fig. 2
Fig. 2
Flow diagram study participation
Fig. 3
Fig. 3
Line of resection and anatomic markings. Red suture: hepatic marking. Blue suture: cranial marking, in the middle of the omentum. Green suture: spleen marking. Dotted line: line of resection distal to the gastroepiploic arcade
See this image and copyright information in PMC

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