Trials (Sep 2024)

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

  • 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

DOI
https://doi.org/10.1186/s13063-024-08396-z
Journal volume & issue
Vol. 25, no. 1
pp. 1 – 10

Abstract

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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.

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