腹腔镜近端胃切除术联合双胃道重建与腹腔镜全胃切除术治疗早期上部胃癌的短期疗效:一项KLASS 05随机临床试验

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
Sun-Hwi Hwang, D. Park, Hyung-Ho Kim, W. Hyung, H. Hur, Han-Kwang Yang, Hyuk-Joon Lee, Hyoung-il Kim, S. Kong, Young Woo Kim, H. Lee, B. Kim, Young-Kyu Park, Young-Joon Lee, Sang-Hoon Ahn, Inseob Lee, Y. Suh, Ji-Ho Park, Soyeon Ahn, Sang-Uk Han
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引用次数: 12

摘要

目的腹腔镜胃近端切除术加双胃道重建(LPG-DTR)是治疗早期上段胃癌(EGC)的一种功能保留手术。然而,很少有研究将LPG-DTR与腹腔镜全胃切除术(LTG)的结果进行比较。本研究旨在比较LTG和上EGC的LPG-DTR的短期疗效。材料和方法对于上三分之一的EGC,进行了一项多中心、前瞻性、随机试验,比较接受LPG-DTR和LTG的患者。短期结果,包括临床病理结果、发病率、死亡率和术后病程,使用基于意向治疗原则和每个方案集的完整分析集进行评估。结果138例符合标准的患者随机分为两组。LPG-DTR组1例患者撤回同意。68例行LPG-DTR, 69例行LTG。手术时间(LPG-DTR=219.4 min;LTG = 201.8分钟;P=0.085),估计失血量(LPG-DTR=76.0 mL;LTG = 66.1毫升;P=0.413),发病率(LPG-DTR=23.5%;LTG = 17.4%;P=0.373),组间差异无统计学意义。两个研究组均未发生死亡。术后2周,两组餐后症状包括反流症状的Visick评分差异无统计学意义(P=0.749)。术后第5天,两组间实验结果无显著差异。结论LPG-DTR治疗上EGC的短期疗效与LTG相当。临床试验注册:ClinicalTrials.gov标识符:NCT02892643
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Short-Term Outcomes of Laparoscopic Proximal Gastrectomy With Double-Tract Reconstruction Versus Laparoscopic Total Gastrectomy for Upper Early Gastric Cancer: A KLASS 05 Randomized Clinical Trial
Purpose 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. Materials and Methods 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. Results 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; P=0.085), estimated blood loss (LPG-DTR=76.0 mL; LTG=66.1 mL; P=0.413), and the morbidity rate (LPG-DTR=23.5%; LTG=17.4%; P=0.373) 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 (P=0.749). Laboratory findings on postoperative day 5 were not significantly different between the groups. Conclusions The short-term outcomes of LPG-DTR for upper EGC were comparable to those of LTG. Trial Registration ClinicalTrials.gov Identifier: NCT02892643
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CiteScore
7.20
自引率
4.30%
发文量
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