食管胃静脉曲张破裂出血是肝硬化门静脉高压症患者最常见的致死因素。我们首先在术中内镜静脉曲张结扎(LSDL)技术的基础上开发了腹腔镜脾切除术和房孔分离(LSD)。在这项研究中,我们旨在评估LSDL是否可行和安全,以及LSDL是否可以有效预防食管胃底静脉曲张再出血(EVR),与单一LSD相比。
在这项随机对照单中心研究中,在2020年1月至2021年12月期间,88例患有食管胃静脉曲张破裂出血和脾功能亢进的肝硬化患者被随机分配接受LSD(n=44)或LSDL(n=44)。主要结果是EVR。
没有患者退出研究。估计的失血量没有显着差异,输血发生率,第一次排气和离床活动的时间,或术后住院时间比较两组。与LSD组相比,LSDL组的手术时间明显更长(138.5±19.4minvs.150.3±19.0分钟,P<0.05);然而,LSDL与1年随访时EVR率显着降低相关(8/44vs.1/44,P<0.05)。单因素分析和多因素logistic回归显示,与LSD相比,LSDL是EVR的独立保护因素(相对风险:0.105,95%置信区间0.012-0.877;P=0.037)。
我们新开发的LSDL程序不仅在技术上是可行和安全的;它也有助于降低EVR风险比单一的LSD。
我们在https://www注册了我们的研究。
gov/。注册的研究名称为“腹腔镜脾切除术和术中内镜下静脉曲张结扎术。“clinicaltrials.gov的试验注册标识符是NCT04244487。
Esophagogastric variceal bleeding is the most common lethal factor for patients with cirrhotic portal hypertension. We firstly developed a laparoscopic splenectomy and azygoportal disconnection (LSD) with intraoperative endoscopic variceal ligation (LSDL) technique. In this
study, we aimed to evaluate whether LSDL is feasible and safe and whether LSDL can effectively prevent esophagogastric variceal re-bleeding (EVR), as compared with single LSD.
In this randomized controlled single-center
study, 88 patients with cirrhosis who had esophagogastric variceal bleeding and hypersplenism were randomly assigned to receive either LSD (n = 44) or LSDL (n = 44) between January 2020 and December 2021. The primary outcome was EVR.
No patients withdrew from the
study. There were no significant differences in estimated blood loss, incidence of blood transfusion, time to first flatus and off-bed activity, or postoperative hospital stay between the two groups. Compared with that in the LSD group, operation time was significantly longer in the LSDL group (138.5 ± 19.4 min vs. 150.3 ± 19.0 min, P < 0.05); however, LSDL was associated with a significantly decreased EVR rate at 1-year follow-up (8/44 vs. 1/44, P < 0.05). Univariate analysis and multivariate logistic regression revealed that LSDL was a significant independent protective factor against EVR in comparison with LSD (relative risk: 0.105, 95% confidence interval 0.012-0.877; P = 0.037).
Our newly developed LSDL procedure is not only technically feasible and safe; it also contributed to lowering the EVR risk more so than single LSD.
We registered our research at https://www.
gov/ . The name of research registered is \"Laparoscopic Splenectomy and Azygoportal Disconnection with Intraoperative Endoscopic Variceal Ligation.\" The
trial registration identifier at clinicaltrials.gov is NCT04244487.