Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
Surg Endosc. 2021 Mar;35(3):1156-1163. doi: 10.1007/s00464-020-07480-0. Epub 2020 Mar 6.
Laparoscopic distal gastrectomy for early gastric cancer has been widely accepted, but laparoscopic total gastrectomy has still not gained popularity because of technical difficulty and unsolved safety issue. We conducted a single-arm multicenter phase II clinical trial to evaluate the safety and the feasibility of laparoscopic total gastrectomy for clinical stage I proximal gastric cancer in terms of postoperative morbidity and mortality in Korea. The secondary endpoint of this trial was comparison of surgical outcomes among the groups that received different methods of esophagojejunostomy (EJ).
The 160 patients of the full analysis set group were divided into three groups according to the method of EJ, the extracorporeal circular stapling group (EC; n = 45), the intracorporeal circular stapling group (IC; n = 64), and the intracorporeal linear stapling group (IL; n = 51). The clinicopathologic characteristics and the surgical outcomes were compared among these three groups.
There were no significant differences in the early complication rates among the three groups (26.7% vs. 18.8% vs. 17.6%, EC vs. IC vs. IL; p = 0.516). The length of mini-laparotomy incision was significantly longer in the EC group than in the IC or IL group. The anastomosis time was significantly shorter in the EC group than in the IL group. The time to first flatus was significantly shorter in the IL group than in the EC group. The long-term complication rate was not significantly different among the three groups (4.4% vs. 12.7% vs. 7.8%; EC vs. IC vs. IL; p = 0.359), however, the long-term incidence of EJ stenosis in IC group (10.9%) was significantly higher than in EC (0%) and IL (2.0%) groups (p = 0.020).
The extracorporeal circular stapling and the intracorporeal linear stapling were safe and feasible in laparoscopic total gastrectomy, however, intracorporeal circular stapling increased EJ stenosis.
腹腔镜下远端胃切除术已广泛应用于早期胃癌的治疗，但由于技术难度和尚未解决的安全性问题，腹腔镜全胃切除术仍未普及。我们进行了一项单臂多中心 II 期临床试验，以评估在韩国，腹腔镜全胃切除术治疗临床 I 期近端胃癌的安全性和可行性，评估指标为术后发病率和死亡率。该试验的次要终点是比较接受不同食管空肠吻合术（EJ）方法的各组之间的手术结果。
全分析集组的 160 例患者根据 EJ 方法分为三组，体外圆形吻合组（EC；n=45）、体内圆形吻合组（IC；n=64）和体内线性吻合组（IL；n=51）。比较三组患者的临床病理特征和手术结果。
三组患者的早期并发症发生率无显著差异（26.7% vs. 18.8% vs. 17.6%，EC vs. IC vs. IL；p=0.516）。EC 组的小切口开腹长度明显长于 IC 组或 IL 组。EC 组的吻合时间明显短于 IL 组。IL 组首次排气时间明显短于 EC 组。三组患者的长期并发症发生率无显著差异（4.4% vs. 12.7% vs. 7.8%；EC vs. IC vs. IL；p=0.359），但 IC 组（10.9%）的 EJ 狭窄发生率明显高于 EC（0%）和 IL（2.0%）组（p=0.020）。
体外圆形吻合和体内线性吻合在腹腔镜全胃切除术中是安全可行的，但体内圆形吻合增加了 EJ 狭窄的风险。
