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Comparison of surgical outcomes among different methods of esophagojejunostomy in laparoscopic total gastrectomy for clinical stage I proximal gastric cancer: results of a single-arm multicenter phase II clinical trial in Korea, KLASS 03.
Surgical Endoscopy ( IF 3.1 ) Pub Date : 2020-03-06 , DOI: 10.1007/s00464-020-07480-0
Han-Kwang Yang 1 , Woo Jin Hyung 2 , Sang-Uk Han 3 , Young-Jun Lee 4 , Joong-Min Park 5 , Gyu Seok Cho 6 , Oh Kyoung Kwon 7 , Seong-Ho Kong 1 , Hyoung-Il Kim 2 , Hyuk-Joon Lee 1 , Wook Kim 8 , Seung Wan Ryu 9 , Sung-Ho Jin 10 , Sung Jin Oh 11 , Keun Won Ryu 12 , Min-Chan Kim 13 , Hye Seong Ahn 14 , Young Kyu Park 15 , Yong Ho Kim 16 , Sun-Hwi Hwang 17 , Jong Won Kim 5 , Jin-Jo Kim 18
Affiliation  

BACKGROUND 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). METHODS 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. RESULTS 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). CONCLUSIONS The extracorporeal circular stapling and the intracorporeal linear stapling were safe and feasible in laparoscopic total gastrectomy, however, intracorporeal circular stapling increased EJ stenosis.

中文翻译:

腹腔镜全胃切除术食管空肠吻合术不同方法在临床I期近端胃癌中手术效果的比较:韩国单臂多中心II期临床试验的结果,KLASS 03。

背景技术用于早期胃癌的腹腔镜远端胃切除术已被广泛接受,但是由于技术上的困难和安全问题尚未解决,腹腔镜全胃切除术仍未得到普及。我们在韩国进行了单臂多中心II期临床试验,以评估腹腔镜全胃切除术治疗I期临床近端胃癌的安全性和可行性,以评估其在韩国的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)的各组的手术结果。方法根据EJ方法,将完整分析组的160例患者分为三组:体外循环吻合器组(EC; n = 45);体内循环吻合器组(IC; n = 64);和体内线性吻合器组(IL; n = 51)。比较这三组的临床病理特征和手术结果。结果三组之间的早期并发症发生率无显着差异(26.7%vs. 18.8%vs. 17.6%,EC vs. IC vs. IL; p = 0.516)。EC组的微型腹腔镜切开术的长度明显长于IC或IL组。EC组的吻合时间明显短于IL组。IL组的首次肠胃气胀时间明显短于EC组。三组的长期并发症发生率无显着差异(4.4%vs. 12.7%vs. 7.8%; EC vs. IC vs. IL; p = 0.359),但是,EJ狭窄的长期发生率IC组(10。9%)显着高于EC(0%)和IL(2.0%)组(p = 0.020)。结论在腹腔镜全胃切除术中,体外环形吻合术和体内线性吻合术是安全可行的,但是,体内环形吻合术可增加EJ狭窄。
更新日期:2020-03-06
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