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

Author

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., and Lissenberg-Witte, B. I.

Subjects
STOMACH cancer, OVERALL survival, BOWEL obstructions, RANDOMIZED controlled trials, PROGRESSION-free survival
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. [ABSTRACT FROM AUTHOR]

Published
2024
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4. Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial

Author

MS CGO, Cancer, 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, MS CGO, Cancer, 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, and Gisbertz, S S

Published
2024

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

Author

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., 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., and Gisbertz, S. S.

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.

Published
2024

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