Department of General Surgery, Zhongshan Hospital, Fudan University, Fenglin Road 180, Shanghai, 200032, China.
Department of General Surgery, Beijing Cancer Hospital, Peking University, Beijing, 100142, China.
BMC Cancer. 2018 Oct 3;18(1):944. doi: 10.1186/s12885-018-4846-z.
The safety of laparoscopic total gastrectomy (LTG) for the treatment of gastric cancer remains lack of clinical evidence. The Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group recently launched a multicenter randomized clinical trial (CLASS02-01) to compare the safety of LTG for clinical stage I gastric cancer with the conventional open total gastrectomy (OTG).
This CLASS02-01 trial is a prospective, multicenter, randomized, controlled, open, and non-inferiority trial. Two hundred patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into LTG group (n = 100) and OTG group (n = 100). The primary purpose of this study is to evaluate the early operative morbidity and mortality of LTG compared with OTG for clinical stage I gastric adenocarcinoma. The second purpose is to evaluate the recovery course and compare the postoperative hospital stay of the patients enrolled in this study.
This CLASS02-01 trial is the first prospective randomized two-arm controlled study to determine the safety of LTG compared with OTG. Through this trial, we hope to show that experienced surgeons can safely perform LTG with lymphadenectomy for gastric cancer.
ClinicalTrials.gov ID: NCT03007550 . December 30, 2016.
腹腔镜全胃切除术（LTG）治疗胃癌的安全性仍缺乏临床证据。中国腹腔镜胃肠外科研究（CLASS）组最近开展了一项多中心随机临床试验（CLASS02-01），旨在比较 LTG 治疗临床Ⅰ期胃癌的安全性与传统开腹全胃切除术（OTG）。
CLASS02-01 试验是一项前瞻性、多中心、随机、对照、开放和非劣效性试验。符合纳入标准且不符合排除标准的 200 例患者将被随机分为 LTG 组（n=100）和 OTG 组（n=100）。本研究的主要目的是评估 LTG 与 OTG 治疗临床Ⅰ期胃腺癌的早期手术并发症发生率和死亡率。次要目的是评估患者的恢复过程，并比较本研究入组患者的术后住院时间。
CLASS02-01 试验是首个前瞻性随机双臂对照研究，旨在确定 LTG 与 OTG 的安全性。通过这项试验，我们希望表明经验丰富的外科医生可以安全地进行 LTG 加淋巴结清扫术治疗胃癌。
ClinicalTrials.gov 注册号：NCT03007550。2016 年 12 月 30 日。
