TY - JOUR
T1 - Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial)
T2 - study protocol for a randomized controlled trial
AU - Keywani, K.
AU - Eshuis, W. J.
AU - Borgstein, A. B.J.
AU - van Det, M. J.
AU - van Duijvendijk, P.
AU - van Etten, B.
AU - Grimminger, P. P.
AU - Heisterkamp, J.
AU - Lagarde, S. M.
AU - Luyer, M. D.P.
AU - Markar, S. R.
AU - Meijer, S. L.
AU - Pierie, J. P.E.N.
AU - Roviello, F.
AU - Ruurda, J. P.
AU - van Sandick, J. W.
AU - Sosef, M.
AU - Witteman, B. P.L.
AU - de Steur, W. O.
AU - Lissenberg-Witte, B. I.
AU - van Berge Henegouwen, M. I.
AU - Gisbertz, S. S.
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/9/4
Y1 - 2024/9/4
N2 - 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.
AB - 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.
KW - Gastric cancer
KW - Omentectomy
KW - Randomized controlled trial
KW - Survival
UR - http://www.scopus.com/inward/record.url?scp=85203070386&partnerID=8YFLogxK
U2 - 10.1186/s13063-024-08396-z
DO - 10.1186/s13063-024-08396-z
M3 - Article
C2 - 39232781
AN - SCOPUS:85203070386
SN - 1745-6215
VL - 25
JO - Trials
JF - Trials
M1 - 588
ER -