Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul National University Hospital, Seoul.
Department of Surgery Yonsei University Severance Hospital, Seoul.
Ann Surg. 2019 Dec;270(6):983-991. doi: 10.1097/SLA.0000000000003217.
The aim of the study was to evaluate the short-term outcomes of KLASS-02-RCT, a multicenter randomized controlled trial comparing laparoscopic distal gastrectomy (LDG) with D2 lymphadenectomy with open distal gastrectomy (ODG).
Although several benefits of laparoscopic gastric cancer surgery have been reported, strong evidence is still limited, especially in locally advanced gastric cancer which requires extensive lymph node dissection.
Enrollment criteria included histologically confirmed cT2-4a and N0-1 gastric adenocarcinoma. Thirty-day morbidity, 90-day mortality, postoperative pain, and recovery were compared between LDG and ODG groups.
A total of 1050 patients were randomly assigned to LDG (n = 526) or ODG group (n = 524) between November 2011 and April 2015. After excluding patients who received bypass or no surgery, 1011 patients were analyzed as actual treatment group. Mean number of totally retrieved lymph nodes was similar in both groups (LDG = 46.6 vs ODG = 47.4, P = 0.451). Early morbidity rate was significantly lower after LDG (16.6%) than after ODG (24.1%; P = 0.003). Postoperative analgesics use and patients' reported pain score were significantly lower after LDG. First day of flatus was earlier after LDG (3.5 vs 3.7 d, P = 0.025) and postoperative hospital stay was shorter in LDG group (8.1 vs 9.3 d, P = 0.005). Ninety days' mortality rate was similar in both groups (LDG = 0.4% vs ODG = 0.6%, P = 0.682).
Laparoscopic distal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer shows benefits in terms of lower complication rate, faster recovery, and less pain compared with open surgery.
本研究旨在评估 KLASS-02-RCT 的短期结果，这是一项多中心随机对照试验，比较了腹腔镜远端胃切除术（LDG）与 D2 淋巴结清扫术的开腹远端胃切除术（ODG）。
尽管已经报道了腹腔镜胃癌手术的一些益处，但仍缺乏强有力的证据，特别是在需要广泛淋巴结清扫的局部进展期胃癌中。
纳入标准包括经组织学证实的 cT2-4a 和 N0-1 胃腺癌。比较 LDG 和 ODG 组之间的 30 天发病率、90 天死亡率、术后疼痛和恢复情况。
2011 年 11 月至 2015 年 4 月期间，共有 1050 例患者被随机分配至 LDG（n = 526）或 ODG 组（n = 524）。排除接受旁路或未手术的患者后，1011 例患者被分析为实际治疗组。两组总的淋巴结检出数相似（LDG = 46.6 对 ODG = 47.4，P = 0.451）。LDG 组的早期发病率（16.6%）显著低于 ODG 组（24.1%；P = 0.003）。LDG 组术后使用止痛药和患者报告的疼痛评分明显较低。LDG 组的肛门排气时间更早（3.5 对 3.7d，P = 0.025），术后住院时间更短（LDG 组 8.1 对 9.3d，P = 0.005）。两组 90 天死亡率相似（LDG = 0.4%对 ODG = 0.6%，P = 0.682）。
对于局部进展期胃癌，腹腔镜 D2 淋巴结清扫远端胃切除术与开腹手术相比，具有并发症发生率低、恢复快、疼痛少的优势。
