Liu Fenglin, Qin Xinyu
Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Feb 25;21(2):121-125.
Many retrospective and cohort studies have shown that laparoscopic total gastrectomy(LTG) has advantages of less trauma, quicker recovery and better incision than open total gastrectomy, and is not inferior to laparotomy in safety and the short- and long-term outcomes, so it has been widely applied. However there is still a lack of high level evidence-based basis. At present, several prospective multicenter clinical studies are being carried out in China, Japan and South Korea which have high incidence of gastric cancer to demonstrate the safety and feasibility of LTG and evaluate its long-term outcomes as well. A multicenter randomized controlled clinical trial comparing the safety of laparoscopic and open radical gastrectomy(CLASS-02 Research) conducted by Professor Sun Yihong, Zhongshan Hospital of Fudan University, is under way. The subjects of this study were the patients with clinical stage I(, the lesion locating in the gastric body, gastric fundus, or the esophagogastric junction (not involving the cardia dentate line), who were expected to be treated with total gastrectomy. The primary outcome measures were early operative morbidity and mortality and the secondary outcome measures were early postoperative recovery course and postoperative hospital stay. It is believed that results of the study will provide a high level evidence-based basis for the safety of LTG. The ongoing JCOG-1401 study in Japan aims to assess the feasibility and safety of LTG and LAPG for the treatment of early gastric cancer. LTG (Roux-en-Y reconstruction) or LAPG (double-tract or jejunal interposition reconstruction) will be performed in patients with clinical stage I( gastric cancer in this study. The primary endpoint of the study is the incidence of anastomotic leakage, and the secondary endpoints are proportion of patients converted to open surgery, the time to the first flatus, analgesic requirement, postoperative body temperature, the overall survival and relapse-free survival. The follow-up time is at least 5 years, and the results will also effectively evaluate the long-term efficacy of LTG and LAPG in the treatment for early gastric cancer. No.10 lymph nodes dissection of D2 total gastrectomy is a major difficulty in LTG. Japanese JCOG-0110 study has showed that for proximal gastric cancer patients without involvement of the greater curvature of the stomach, routine splenectomy for No.10 lymph nodes dissection is not recommended. In this regard, Professor Huang Changming, Union Hospital of Fujian Medical University, led the ongoing CLASS-04 study to evaluate the safety, feasibility and clinical efficacy of laparoscopic No.10 lymph node dissection with spleen preservation for patients with locally advanced gastric cancer locating in the upper part of the stomach. The ongoing CLASS-02 and JCOG-1401 studies will answer whether LTG is suitable for the treatment of early gastric cancer. We believe that in the absence of high level evidence-based basis, LTG should be applied cautiously to advanced gastric cancer, and LTG for early gastric cancer patients should also be operated by experienced surgeons.
许多回顾性研究和队列研究表明,腹腔镜全胃切除术(LTG)与开放全胃切除术相比,具有创伤小、恢复快、切口美观等优点,在安全性及短期和长期疗效方面并不逊色于开腹手术,因此得到了广泛应用。然而,目前仍缺乏高水平的循证医学依据。目前,中国、日本和韩国等胃癌高发国家正在开展多项前瞻性多中心临床研究,以论证LTG的安全性和可行性,并评估其长期疗效。复旦大学附属中山医院孙益红教授主持的一项比较腹腔镜与开放根治性胃切除术安全性的多中心随机对照临床试验(CLASS-02研究)正在进行中。该研究的对象为临床分期为I期(病变位于胃体、胃底或食管胃交界部(不涉及贲门齿状线))、预计行全胃切除术的患者。主要观察指标为早期手术并发症发生率和死亡率,次要观察指标为术后早期恢复过程和术后住院时间。相信该研究结果将为LTG的安全性提供高水平的循证医学依据。日本正在进行的JCOG-1401研究旨在评估LTG和LAPG治疗早期胃癌的可行性和安全性。本研究将对临床分期为I期(的胃癌患者行LTG(Roux-en-Y重建)或LAPG(双通道或空肠间置重建)。该研究的主要终点是吻合口漏的发生率,次要终点是中转开腹手术患者的比例、首次排气时间、镇痛需求、术后体温、总生存期和无复发生存期。随访时间至少5年,研究结果也将有效评估LTG和LAPG治疗早期胃癌的长期疗效。D2全胃切除术中第10组淋巴结清扫是LTG的一大难点。日本JCOG-0110研究表明,对于胃大弯未受累的近端胃癌患者,不建议常规行脾切除术以清扫第10组淋巴结。对此,福建医科大学附属协和医院黄昌明教授牵头开展了正在进行的CLASS-04研究,以评估腹腔镜保留脾脏清扫第10组淋巴结治疗胃上部局部进展期胃癌患者的安全性、可行性和临床疗效。正在进行的CLASS-02和JCOG-1401研究将回答LTG是否适合治疗早期胃癌。我们认为,在缺乏高水平循证医学依据的情况下,LTG应用于进展期胃癌时应谨慎,对于早期胃癌患者行LTG手术也应由经验丰富的外科医生进行。