We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial.
- Authors
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.
- 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.
- Subjects
STOMACH cancer; OVERALL survival; BOWEL obstructions; RANDOMIZED controlled trials; PROGRESSION-free survival
- Publication
Trials, 2024, Vol 25, Issue 1, p1
- ISSN
1745-6215
- Publication type
Article
- DOI
10.1186/s13063-024-08396-z