Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765).
Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765).
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DOI：
10.1136/bmjopen-2022-064286
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发表时间：
2022-10-31
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
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大多数胃癌的唯一治疗方法是根治性胃切除术和 D2 淋巴结切除术 (LAD)。微创全胃切除术（MIG）旨在降低术后发病率，但其应用尚未在西方国家广泛建立。微创与开腹全胃切除术是第一个比较 MIG 与开腹全胃切除术 (OG) 术后发病率的西方多中心随机对照试验 (RCT)。这项优越性多中心随机对照试验将 D2 或 D2+LAD 肿瘤全胃切除术的 MIG（干预）与 OG（对照）进行了比较。招聘预计持续2年。纳入标准包括年龄在 18 岁至 84 岁之间以及初步诊断为胃癌后计划进行全胃切除术。排除标准包括东部肿瘤合作组（ECOG）体能状态>2、需要扩大胃切除术或少于全胃切除术的肿瘤、既往腹部手术或严重并发MIG的广泛粘连、其他活动性肿瘤疾病、晚期（T4或M1）、紧急情况和妊娠。样本量按每组 80 名参与者计算。主要终点是通过综合并发症指数衡量的术后 30 天发病率。次要终点包括术后发病率和死亡率、对快速通道方案的遵守情况和患者报告的生活质量 (QoL) 评分（QoR-15、EUROQOL EuroQol-5 Dimensions-5 级别 (EQ-5D)、EORTC QLQ-C30、EORTC QLQ-STO22、日常生活活动和身体形象量表）。肿瘤学终点包括 R0 切除率、淋巴结产量、无病生存率和 60 个月随访时的总生存率。海德堡大学医学院独立伦理委员会 (S-816/2021) 已收到伦理批准，并将在招募前从每个参与中心的负责伦理委员会收到伦理批准。结果将开放获取发布。 DRKS00025765。
The only curative treatment for most gastric cancer is radical gastrectomy with D2 lymphadenectomy (LAD). Minimally invasive total gastrectomy (MIG) aims to reduce postoperative morbidity, but its use has not yet been widely established in Western countries. Minimally invasivE versus open total GAstrectomy is the first Western multicentre randomised controlled trial (RCT) to compare postoperative morbidity following MIG vs open total gastrectomy (OG). This superiority multicentre RCT compares MIG (intervention) to OG (control) for oncological total gastrectomy with D2 or D2+LAD. Recruitment is expected to last for 2 years. Inclusion criteria comprise age between 18 and 84 years and planned total gastrectomy after initial diagnosis of gastric carcinoma. Exclusion criteria include Eastern Co-operative Oncology Group (ECOG) performance status >2, tumours requiring extended gastrectomy or less than total gastrectomy, previous abdominal surgery or extensive adhesions seriously complicating MIG, other active oncological disease, advanced stages (T4 or M1), emergency setting and pregnancy. The sample size was calculated at 80 participants per group. The primary endpoint is 30-day postoperative morbidity as measured by the Comprehensive Complications Index. Secondary endpoints include postoperative morbidity and mortality, adherence to a fast-track protocol and patient-reported quality of life (QoL) scores (QoR-15, EUROQOL EuroQol-5 Dimensions-5 Levels (EQ-5D), EORTC QLQ-C30, EORTC QLQ-STO22, activities of daily living and Body Image Scale). Oncological endpoints include rate of R0 resection, lymph node yield, disease-free survival and overall survival at 60-month follow-up. Ethical approval has been received by the independent Ethics Committee of the Medical Faculty, University of Heidelberg (S-816/2021) and will be received from each responsible ethics committee for each individual participating centre prior to recruitment. Results will be published open access. DRKS00025765.
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影响因子：
168.9
作者：
Lacy, AM;García-Valdecasas, JC;Visa, J
通讯作者：
Visa, J
DOI：
10.1007/s00464-012-2758-6
发表时间：
2013-07-01
影响因子：
3.1
作者：
Jiang, Lei;Yang, Ke-Hu;Yao, Liang
通讯作者：
Yao, Liang
影响因子：
9.6
作者：
Chok, K. S.;Ng, K. K.;Fan, S. T.
通讯作者：
Fan, S. T.
影响因子：
9
作者：
Harrison, LE;Karpeh, MS;Brennan, MF
通讯作者：
Brennan, MF
影响因子：
7.4
作者：
通讯作者：
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