一项多中心前瞻性随机对照临床试验（III 期）比较腹腔镜辅助远端胃癌根治术与全腹腔镜远端胃癌根治术治疗胃癌患者生活质量的差异（研究方案）。
A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol).
机构信息
Department of Surgery, Korea University College of Medicine, Seoul, Korea.
Department of Surgery, Gyeongsang National University School of Medicine, Jinju, Korea.
出版信息
BMC Cancer. 2019 Mar 7;19(1):206. doi: 10.1186/s12885-019-5396-8.
BACKGROUND
KLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer, named as KLASS 07, has been currently prepared in Korea.
METHODS
Patients diagnosed as gastric cancer, with clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the Americal Joint Committee on Cancer System, were randomized to receive either TLDG or LADG. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 gastrectomies and at least 30 gastrectomies annually (regardless of open or laparoscopic surgery for gastric cancer). The patients who are allocated to TLDG group undergo intracorporeal anastomosis and those who are assigned to LADG undergo extracorporeal anastomosis for gastrointestinal reconstruction.
DISCUSSION
Thirty-one surgeons from 26 institutions were engaged in this trial. The primary endpoint is 30-day morbidity, and secondary endpoint is QOL assessed by the questionnaire score. The KLASS 07 trial is the first multi-center RCT to investigate whether there are significant and quantifiable differences between the QOL of TLDG and LADG. The findings from this trial are expected to be the critical clues for designing the detailed procedures during laparoscopic surgery for gastric cancer.
TRIAL REGISTRATION
The protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).
背景
KLASS（韩国腹腔镜胃肠外科研究）是一个历史悠久的研究小组，它在韩国确立了胃肠疾病的腹腔镜手术，并进行了一些重要的研究，为腹腔镜胃肠手术的合理性提供了依据。目前，韩国正在准备一项多中心随机对照试验（RCT），比较完全腹腔镜远端胃切除术（TLDG）和腹腔镜辅助远端胃切除术（LADG）治疗胃癌患者的生活质量（QOL），该试验名为 KLASS 07。
方法
根据第 7 版美国癌症联合委员会（AJCC）分期系统，诊断为胃癌且临床分期为 IA（T1N0M0）或 IB（T1N1M0/T2N0M0）的患者被随机分配接受 TLDG 或 LADG。为了进行手术质量控制，参与该试验的外科医生必须至少进行 50 例胃切除术，且每年至少进行 30 例胃切除术（无论是否为开腹或腹腔镜下胃癌手术）。分配到 TLDG 组的患者进行体内吻合，分配到 LADG 组的患者进行体外吻合进行胃肠重建。
讨论
来自 26 家机构的 31 名外科医生参与了这项试验。主要终点是 30 天发病率，次要终点是通过问卷评分评估的 QOL。KLASS 07 试验是第一项旨在研究 TLDG 和 LADG 之间的 QOL 是否存在显著和可量化差异的多中心 RCT。该试验的结果有望为腹腔镜胃癌手术的详细操作提供重要线索。
试验注册
KLASS 07（CKLASS 01）的方案已在 http://register.clinicaltrials.gov 上注册，注册号为 NCT03393182（注册日期：2018 年 1 月 2 日）。
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