Hwang Sun-Hwi, Park Do Joong, Kim Hyung-Ho, Hyung Woo Jin, Hur Hoon, Yang Han-Kwang, Lee Hyuk-Joon, Kim Hyoung-Il, Kong Seong-Ho, Kim Young Woo, Lee Han Hong, Kim Beom Su, Park Young-Kyu, Lee Young-Joon, Ahn Sang-Hoon, Lee In-Seob, Suh Yun-Suhk, Park Ji-Ho, Ahn Soyeon, Han Sang-Uk
Department of Surgery, Research Institute for Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital, Yangsan, Korea.
Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group, Seoul, Korea.
J Gastric Cancer. 2022 Apr;22(2):94-106. doi: 10.5230/jgc.2022.22.e8.
Laparoscopic proximal gastrectomy with double-tract reconstruction (LPG-DTR) is a function-preserving procedure performed for treating upper early gastric cancer (EGC). However, few studies have compared the outcomes of LPG-DTR with those of laparoscopic total gastrectomy (LTG). This study aimed at comparing the short-term outcomes of LPG-DTR between LTG and upper EGC.
For upper-third EGC, a multicenter, prospective, randomized trial was performed to compare those who underwent LPG-DTR with those who underwent LTG. Short-term outcomes, including clinicopathologic results, morbidity, mortality, and postoperative courses, were evaluated using a full analysis set based on the intention-to-treat principle and the per-protocol set.
Of the patients, 138 who fulfilled the criteria were randomized to each group. One patient in the LPG-DTR group withdrew consent. Sixty-eight patients underwent LPG-DTR and 69 underwent LTG. The operative time (LPG-DTR=219.4 minutes; LTG=201.8 minutes; P0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P0.373) between the groups were not significantly different. No mortality occurred in either of the study groups. Two weeks post operation, the Visick scores for postprandial symptoms, including reflux symptoms, were not significantly different between the groups (P0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups.
The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG.
ClinicalTrials.gov Identifier: NCT02892643.
腹腔镜近端胃切除术联合双通道重建术（LPG-DTR）是一种用于治疗早期上段胃癌（EGC）的保留功能手术。然而，很少有研究比较LPG-DTR与腹腔镜全胃切除术（LTG）的治疗效果。本研究旨在比较LTG与LPG-DTR治疗早期上段胃癌的短期疗效。
针对上段三分之一EGC患者，开展了一项多中心、前瞻性、随机试验，比较接受LPG-DTR的患者与接受LTG的患者。基于意向性分析原则和符合方案集，使用完整分析集评估短期疗效，包括临床病理结果、发病率、死亡率和术后病程。
符合标准的患者中，每组随机分配138例。LPG-DTR组有1例患者撤回同意。68例患者接受了LPG-DTR，69例接受了LTG。两组之间的手术时间（LPG-DTR = 219.4分钟；LTG = 201.8分钟；P>0.085）、估计失血量（LPG-DTR = 76.0毫升；LTG = 66.1毫升；P>0.413）和发病率（LPG-DTR = 23.5%；LTG = 17.4%；P>0.373）无显著差异。两个研究组均未发生死亡。术后两周，两组间餐后症状（包括反流症状）的Visick评分无显著差异（P>0.749）。术后第5天的实验室检查结果在两组间无显著差异。
LPG-DTR治疗早期上段胃癌的短期疗效与LTG相当。
ClinicalTrials.gov标识符：NCT02892643。
