Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT)
Short-term Outcomes of a Multicenter Randomized Controlled Trial Comparing Laparoscopic Distal Gastrectomy With D2 Lymphadenectomy to Open Distal Gastrectomy for Locally Advanced Gastric Cancer (KLASS-02-RCT)
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DOI：
10.1097/sla.0000000000003217
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发表时间：
2019-12-01
影响因子：
9
通讯作者：
Kim, Min-Chan
中科院分区：
文献类型：
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作者：
Lee, Hyuk-Joon;Hyung, Woo Jin;Kim, Min-Chan
目的：本研究的目的是评估KLASS-02-RCT的短期结局，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淋巴结切除术和开放式远端胃切除术（ODG）。虽然腹腔镜胃癌手术的几个好处已经报道，有力的证据仍然有限，方法：入选标准包括组织学证实的cT 2 -4a和N 0 -1胃腺癌。结果：2011年11月至2015年4月期间，共1050例患者被随机分为LDG组（n = 526）和ODG组（n = 524）。排除接受旁路手术或未手术的患者后，将1011例患者作为实际治疗组进行分析。两组的平均完全回收淋巴结数量相似（LDG = 46.6 vs ODG = 47.4，P = 0.451）。LDG后早期发病率（16.6%）显著低于ODG后（24.1%; P = 0.003）。LDG后，术后镇痛药使用和患者报告的疼痛评分显著降低。LDG组术后第1天肛门排气时间早于LDG组（3.5 vs 3.7 d，P = 0.025），术后住院时间短于LDG组（8.1 vs 9.3 d，P = 0.005）。两组90 d死亡率相似（LDG = 0.4%vs ODG = 0.6%，P = 0.682）。结论：腹腔镜远端胃切除联合D2淋巴结清扫术治疗局部进展期胃癌与开腹手术相比，具有并发症少、恢复快、疼痛轻等优点。
Objective: 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).Summary Background Data: 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.Methods: 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.Results: 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).Conclusions: 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.