State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.
Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, HeFei, Anhui, China.
JAMA Surg. 2019 Jul 1;154(7):610-616. doi: 10.1001/jamasurg.2019.0153.
Peritoneal metastasis is the most frequent pattern of postoperative recurrence in patients with gastric cancer. Extensive intraoperative peritoneal lavage (EIPL) is a new prophylactic strategy for treatment of peritoneal metastasis of locally advanced gastric cancer; however, the safety and efficacy of EIPL is currently unknown.
To evaluate short-term outcomes of patients with advanced gastric cancer who received combined surgery and EIPL or surgery alone.
DESIGN, SETTING, AND PARTICIPANTS: From March 2016 to November 2017, 662 patients with advanced gastric cancer receiving D2 gastrectomy were enrolled in a large, multicenter, randomized clinical trial from 11 centers across China. In total, 329 patients were randomly assigned to receive surgery alone, and 333 patients were randomly assigned to receive surgery plus EIPL. Clinical characteristics, operative findings, and postoperative short-term outcomes were compared between the 2 groups in the intent-to-treat population.
Short-term postoperative complications and mortality.
The present analysis included data from 550 patients, 390 men and 160 women, with a mean (SD) age of 60.8 (10.7) years in the surgery alone group and 60.6 (10.8) in the surgery plus EIPL group. Patients assigned to the surgery plus EIPL group exhibited reduced mortality (0 of 279 patients) compared with those assigned to surgery alone (5 of 271 patients [1.9%]) (difference, 1.9%; 95% CI, 0.3%-3.4%; P = .02). A significant difference in the overall postoperative complication rate was observed between patients receiving surgery alone (46 patients [17.0%]) and those receiving surgery plus EIPL (31 patients [11.1%]) (difference, 5.9%; 95% CI, 0.1%-11.6%; P = .04). Postoperative pain occurred more often following surgery alone (48 patients [17.7%]) than following surgery plus EIPL (30 patients [10.8%]) (difference, 7.0%; 95% CI, 0.8%-13.1%; P = .02).
Inclusion of EIPL can increase the safety of D2 gastrectomy and decrease postoperative short-term complications and wound pain. As a new, safe, and simple procedure, EIPL therapy is easily performed anywhere and does not require any special devices or techniques. Our study suggests that patients with advanced gastric cancer appear to be candidates for the EIPL approach.
ClinicalTrials.gov identifier: NCT02745509.
腹膜转移是胃癌患者术后复发最常见的模式。广泛的术中腹腔灌洗（EIPL）是治疗局部进展期胃癌腹膜转移的一种新的预防策略；然而，EIPL 的安全性和疗效目前尚不清楚。
评估接受联合手术和 EIPL 或单纯手术治疗的晚期胃癌患者的短期结果。
设计、地点和参与者：2016 年 3 月至 2017 年 11 月，来自中国 11 个中心的 662 名接受 D2 胃切除术的晚期胃癌患者参加了一项大型、多中心、随机临床试验。共有 329 名患者被随机分配接受单纯手术治疗，333 名患者被随机分配接受手术加 EIPL。在意向治疗人群中，比较了两组的临床特征、手术发现和术后短期结果。
短期术后并发症和死亡率。
本分析包括 550 名患者的数据，其中 390 名男性和 160 名女性，单纯手术组的平均（SD）年龄为 60.8（10.7）岁，手术加 EIPL 组为 60.6（10.8）岁。与单独接受手术的患者（271 例中的 5 例[1.9%]）相比，接受手术加 EIPL 的患者死亡率（279 例中的 0 例）降低（差异，1.9%；95%CI，0.3%-3.4%；P=0.02）。单独接受手术的患者（46 例[17.0%]）和接受手术加 EIPL 的患者（31 例[11.1%]）的总术后并发症发生率存在显著差异（差异，5.9%；95%CI，0.1%-11.6%；P=0.04）。与单独接受手术相比，接受手术加 EIPL 的患者术后疼痛更常见（48 例[17.7%]）（差异，7.0%；95%CI，0.8%-13.1%；P=0.02）。
纳入 EIPL 可提高 D2 胃切除术的安全性，降低术后短期并发症和伤口疼痛。作为一种新的、安全且简单的程序，EIPL 治疗可以在任何地方轻松进行，不需要任何特殊设备或技术。我们的研究表明，晚期胃癌患者似乎是 EIPL 方法的候选者。
ClinicalTrials.gov 标识符：NCT02745509。
