Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol.
Assessment of laparoscopic stomach preserving surgery with sentinel basin dissection versus standard gastrectomy with lymphadenectomy in early gastric cancer-A multicenter randomized phase III clinical trial (SENORITA trial) protocol.
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DOI：
10.1186/s12885-016-2336-8
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发表时间：
2016-05-31
期刊：
影响因子：
3.8
通讯作者：
Eom BW
中科院分区：
文献类型：
--
作者：
Park JY;Kim YW;Ryu KW;Nam BH;Lee YJ;Jeong SH;Park JH;Hur H;Han SU;Min JS;An JY;Hyung WJ;Cho GS;Jeong GA;Jeong O;Park YK;Jung MR;Yoon HM;Eom BW
沿着在东方国家早期胃癌（EGC）的显著增加，人们一直在努力在EGC中采用前哨淋巴结的概念以保护胃功能并减少术后并发症的发生。基于先前质量控制研究的有希望的结果，这项前瞻性多中心随机对照III期临床试验旨在阐明与标准腹腔镜胃切除术相比，采用前哨盆剥离（SBD）的腹腔镜胃保留手术的肿瘤学安全性。本试验是一项非劣效性设计的药物启动、开放标签、多中心随机对照III期试验。诊断为临床分期T1N0M0胃腺癌的单个病灶，直径≤ 3 cm的患者有资格参加本研究。共580例患者（每组290例）将被随机分配至SBD腹腔镜保胃手术或标准手术。主要终点是3年无病生存期（DFS），次要终点包括术后发病率和死亡率、生活质量、5年DFS和总生存期。仅允许完成既往质量控制研究的合格研究者参与本III期临床试验。这项拟议的试验预计将验证与EGC患者的标准胃切除术相比，SBD的腹腔镜胃保留手术是否能实现相似的肿瘤学结局并改善生活质量。本研究于2013年3月4日在NIHClinicalTrial.gov数据库（NCT 01804998）中注册。
Along with the marked increase in early gastric cancer (EGC) in the Eastern countries, there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications. Based on promising results from a previous quality control study, this prospective multicenter randomized controlled phase III clinical trial aims to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to a standard laparoscopic gastrectomy. This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma, with a diameter of 3 cm or less are eligible for the present study. A total of 580 patients (290 per group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, 5-year DFS, and overall survival. Qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial. The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves similar oncologic outcomes and improved quality of life compared to a standard gastrectomy in EGC patients. This study was registered at the NIH ClinicalTrial.gov database (NCT01804998) on March 4th, 2013.