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保留大网膜与胃癌根治术中完全切除大网膜的随机对照研究(OMEGA 试验):研究方案

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

机构信息

Amsterdam UMC Location, Department of Surgery, Amsterdam, the Netherlands.

Cancer Center Amsterdam, Cancer Treatment and Quality of Life, Amsterdam, the Netherlands.

出版信息

Trials. 2024 Sep 4;25(1):588. doi: 10.1186/s13063-024-08396-z.

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 January 2022.

摘要

背景

局部晚期胃癌的潜在治愈性治疗包括胃切除术,通常与围手术期化疗联合进行。肿瘤切除术包括根治性(R0)胃切除术和改良 D2 淋巴结清扫术;通常还进行全大网膜切除术,以确保切除可能的显微镜下疾病。然而,大网膜作为区域免疫反应的调节剂发挥作用,以防止感染并防止可能导致肠梗阻的粘连。缺乏常规根治性全大网膜切除术在胃切除术中可带来生存获益的证据。

方法

OMEGA 是一项随机对照、开放、平行、非劣效、多中心试验。符合条件的患者可手术(ASA<4)和可切除(≦cT4aN3bM0)原发性胃癌。患者将以 1:1 比例随机分为胃网膜血管远端保留网膜的(部分)全胃切除术与完全大网膜切除术。为了达到 80%的效力,目标样本量为 654 例患者。主要目的是研究在胃癌的胃切除术中保留网膜是否在 3 年总生存率方面不劣于完全大网膜切除术。次要终点包括术中及术后结局,如出血量、手术时间、住院时间、再入院率、生活质量、无病生存率和成本效益。

讨论

OMEGA 试验研究在胃癌的胃切除术中保留网膜是否在 3 年总生存率方面不劣于完全大网膜切除术,非劣效性基于意向治疗和方案分析的结果来确定。OMEGA 试验将阐明是否可以省略常规的完全大网膜切除术,从而有可能减少过度治疗。

试验注册

ClinicalTrials.gov NCT05180864。于 2022 年 1 月 6 日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6c16/11375919/f25ed35e4b78/13063_2024_8396_Fig1_HTML.jpg

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