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: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, 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-WitteM I van Berge Henegouwen, S S Gisbertz

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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 6^th January 2022.

Original language	English
Article number	588
Number of pages	10
Journal	Trials
Volume	25
Issue number	1
DOIs	https://doi.org/10.1186/s13063-024-08396-z
Publication status	Published - 4 Sept 2024

Keywords

Adult
Aged
Disease-Free Survival
Equivalence Trials as Topic
Female
Gastrectomy/adverse effects
Humans
Lymph Node Excision/adverse effects
Male
Middle Aged
Multicenter Studies as Topic
Omentum/surgery
Organ Sparing Treatments/methods
Quality of Life
Randomized Controlled Trials as Topic
Stomach Neoplasms/surgery
Time Factors
Treatment Outcome

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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., ... Gisbertz, S. S. (2024). Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial. Trials, 25(1), Article 588. https://doi.org/10.1186/s13063-024-08396-z

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

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 = "Adult, Aged, Disease-Free Survival, Equivalence Trials as Topic, Female, Gastrectomy/adverse effects, Humans, Lymph Node Excision/adverse effects, Male, Middle Aged, Multicenter Studies as Topic, Omentum/surgery, Organ Sparing Treatments/methods, Quality of Life, Randomized Controlled Trials as Topic, Stomach Neoplasms/surgery, Time Factors, Treatment Outcome",

author = "K Keywani and Eshuis, {W J} and Borgstein, {A B J} and {van Det}, {M J} and {van Duijvendijk}, P and {van Etten}, B and Grimminger, {P P} and J Heisterkamp and Lagarde, {S M} and Luyer, {M D P} and Markar, {S R} and Meijer, {S L} and Pierie, {J P E N} and F Roviello and Ruurda, {J P} and {van Sandick}, {J W} and M Sosef and Witteman, {B P L} and {de Steur}, {W O} and Lissenberg-Witte, {B I} and {van Berge Henegouwen}, {M I} and Gisbertz, {S S}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = sep,

day = "4",

doi = "10.1186/s13063-024-08396-z",

language = "English",

volume = "25",

journal = "Trials",

issn = "1745-6215",

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Keywani, K, Eshuis, WJ, Borgstein, ABJ, van Det, MJ, van Duijvendijk, P, van Etten, B, Grimminger, PP, Heisterkamp, J, Lagarde, SM, Luyer, MDP, Markar, SR, Meijer, SL, Pierie, JPEN, Roviello, F, Ruurda, JP, van Sandick, JW, Sosef, M, Witteman, BPL, de Steur, WO, Lissenberg-Witte, BI, van Berge Henegouwen, MI & Gisbertz, SS 2024, 'Omentum preservation versus complete omentectomy in gastrectomy for gastric cancer (OMEGA trial): study protocol for a randomized controlled trial', Trials, vol. 25, no. 1, 588. https://doi.org/10.1186/s13063-024-08396-z

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 - Adult

KW - Aged

KW - Disease-Free Survival

KW - Equivalence Trials as Topic

KW - Female

KW - Gastrectomy/adverse effects

KW - Humans

KW - Lymph Node Excision/adverse effects

KW - Male

KW - Middle Aged

KW - Multicenter Studies as Topic

KW - Omentum/surgery

KW - Organ Sparing Treatments/methods

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Stomach Neoplasms/surgery

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1186/s13063-024-08396-z

DO - 10.1186/s13063-024-08396-z

M3 - Article

C2 - 39232781

SN - 1745-6215

VL - 25

JO - Trials

JF - Trials

IS - 1

M1 - 588

ER -

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

Abstract

Keywords

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