Department of Surgery, Chonnam National University Hwasun Hospital, Hwasun-gun, Republic of Korea.
Center for Gastric Cancer, National Cancer Center, Goyang-si, Republic of Korea.
Ann Surg. 2018 Apr;267(4):638-645. doi: 10.1097/SLA.0000000000002168.
This randomized, phase II, multicenter clinical trial was conducted to evaluate the feasibility of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection compared with open distal gastrectomy (ODG) for the treatment of advanced gastric cancer (AGC).
D2 lymph node dissection has been accepted as standard treatment for AGC. Although LADG is widely performed in early gastric cancer (EGC), the feasibility of LADG in AGC has not been proven yet.
Patients with cT2-T4a and cN0-2 (AJCC 7 staging system) distal gastric cancer were randomly but not blindingly assigned to LADG or ODG groups using fixed block sizes with a 1:1 allocation ratio. The primary endpoint was the noncompliance rate of the lymph node dissection, which was used to evaluate feasibility. Secondary endpoints included 3-year disease-free survival (DFS), 5-year overall survival, complications, and surgical stress response.
Between June 2010 and October 2011, 204 patients enrolled and underwent either LADG (n = 105) or ODG (n = 99). Of these, 196 patients (100 in LADG and 96 in ODG) were included in the intention-to-treat analysis. There were no significant differences in the overall noncompliance rate of lymph node dissection between LADG and ODG groups (47.0% and 43.2%, respectively; P = 0.648). In the subgroup analysis, the noncompliance rate in the LADG group was significantly higher than the ODG group for clinical stage III disease (52.0% vs 25.0%, P = 0.043). No difference was found in the 3-year DFS rate between the groups (LADG, 80.1%; ODG, 81.9%; P = 0.448). Differences in postoperative complication rates and surgical stress response were found to be insignificant between the 2 arms.
LADG was feasible for AGC treatment based on the noncompliance rate of D2 lymph node dissection. Subgroups analysis data suggest that further studies are needed for stage III gastric cancer.
本随机、二期、多中心临床试验旨在评估腹腔镜辅助远端胃切除术（LADG）联合 D2 淋巴结清扫术与开腹远端胃切除术（ODG）治疗进展期胃癌（AGC）的可行性。
D2 淋巴结清扫术已被接受为 AGC 的标准治疗方法。虽然 LADG 在早期胃癌（EGC）中广泛应用，但 LADG 在 AGC 中的可行性尚未得到证实。
本研究采用固定大小的随机分组（n = 105）和 1:1 分配比，将 cT2-T4a 和 cN0-2（AJCC 7 分期系统）远端胃癌患者随机分配至 LADG 或 ODG 组。主要终点是淋巴结清扫术的不符合率，用于评估可行性。次要终点包括 3 年无病生存率（DFS）、5 年总生存率、并发症和手术应激反应。
2010 年 6 月至 2011 年 10 月，共有 204 例患者入组并接受 LADG（n = 105）或 ODG（n = 99）治疗。其中，196 例患者（LADG 组 100 例，ODG 组 96 例）被纳入意向治疗分析。LADG 和 ODG 组的总体淋巴结清扫术不符合率无显著差异（分别为 47.0%和 43.2%；P = 0.648）。在亚组分析中，LADG 组在临床分期为 III 期的患者中，淋巴结清扫术不符合率显著高于 ODG 组（52.0%比 25.0%；P = 0.043）。两组 3 年 DFS 率无差异（LADG 组 80.1%，ODG 组 81.9%；P = 0.448）。两组术后并发症发生率和手术应激反应差异无统计学意义。
基于 D2 淋巴结清扫术的不符合率，LADG 治疗 AGC 是可行的。亚组分析数据表明，需要进一步研究 III 期胃癌。
