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日本多中心前瞻性队列研究设计:使用网络注册系统(J-WEB/EGC)进行早期胃癌内镜切除术。

Design of Japanese multicenter prospective cohort study of endoscopic resection for early gastric cancer using Web registry (J-WEB/EGC).

机构信息

Endoscopy Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.

出版信息

Gastric Cancer. 2012 Oct;15(4):451-4. doi: 10.1007/s10120-012-0159-0. Epub 2012 May 2.

DOI:10.1007/s10120-012-0159-0
PMID:22549754
Abstract

A Japanese multicenter prospective cohort study is currently being conducted on endoscopic resection (ER) for early gastric cancer (EGC) using a Web registry system developed to determine short-term and long-term outcomes based on the absolute and expanded indications. All consecutive patients with EGC or suspected EGC undergoing ER at the 41 participating institutions from July 2010 to June 2012 are being enrolled in the study cohort using the Web registry system, and each patient will be followed up for a minimum of 5 years. The study investigation includes baseline patient and lesion characteristics as well as short-term and long-term outcomes. A survey program to collect information on long-term outcomes is also being introduced for patients subsequently followed up in institutions other than their original participating institutions, as well as patients for whom the original participating institutions have been losing track of their follow-up. The primary endpoint is 5-year overall survival, with en bloc resection, curative resection, complication, local recurrence, distant metastasis, metachronous EGC, and recurrence-free survival being secondary endpoints in addition to the successful collection of long-term outcome data on enrolled patients utilizing the survey program.

摘要

一项针对日本早期胃癌内镜切除术(ER)的多中心前瞻性队列研究正在进行中,该研究使用一个网络注册系统,根据绝对和扩展的适应证来确定短期和长期结果。自 2010 年 7 月至 2012 年 6 月,共有 41 家参与机构的所有连续患有早期胃癌或疑似早期胃癌并接受 ER 治疗的患者正在使用网络注册系统纳入研究队列,并且每位患者将至少随访 5 年。该研究调查包括基线患者和病变特征以及短期和长期结果。还为在原始参与机构以外的机构接受随访的患者以及原始参与机构无法追踪其随访的患者引入了一项长期结果信息收集调查计划。主要终点是 5 年总生存率,除了成功利用调查计划收集入组患者的长期结果数据外,整块切除、治愈性切除、并发症、局部复发、远处转移、异时性 EGC 和无复发生存率为次要终点。

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