改良保留迷走神经与传统腹腔镜脾切除联合贲门周围血管离断术治疗肝硬化门静脉高压症的前瞻性随机对照研究

Modified vagus nerve⁃preserving versus conventional laparoscopic splenectomy and azygoportal disconnec⁃tion for cirrhotic portal hypertension:a prospective randomized controlled trial

目的探讨改良保留迷走神经与传统腹腔镜脾切除联合贲门周围血管离断术治疗肝硬化门静脉高压症的临床疗效。方法采用前瞻性随机对照研究方法。选取2018年4月至2019年2月扬州大学临床医学院收治的70例肝硬化门静脉高压症患者的临床病理资料。将研究对象按照随机数字表法分为传统手术组和改良手术组,传统手术组患者行传统腹腔镜脾切除联合贲门周围血管离断术,改良手术组患者行改良保留迷走神经腹腔镜脾切除联合贲门周围血管离断术。观察指标:(1)术中及术后情况。(2)随访情况。采用电话、门诊和住院方式进行随访。术后每3个月随访了解患者上消化道再出血、胃潴留、餐后饱胀、腹泻发生情况。术后1、6、12个月行电子胃镜检查,如食管曲张静脉直径>5 mm,则行内镜下套扎术。随访时间截至2020年2月。正态分布的计量资料以x±s表示,组间比较采用t检验;偏态分布的计量资料以M(范围)表示;计数资料以绝对数表示,组间比较采用χ^2检验或Fisher确切概率法。结果筛选出符合研究条件的肝硬化门静脉高压症患者70例,男51例,女19例;年龄为(52±12)岁,年龄范围为22~78岁;传统手术组和改良手术组各35例,研究过程中传统手术组1例患者退出。(1)术中及术后情况:传统手术组患者手术时间、术中出血量、术中输血、中转开腹分别为(160±26)min、(76±104)mL、0、1例,改良手术组上述指标分别为(135±27)min、(65±68)mL、1例、0。两组患者手术时间比较,差异有统计学意义(t=-3.946,P<0.05),术中出血量比较,差异无统计学意义(t=-0.562,P>0.05);术中输血、中转开腹比较,差异均无统计学意义(P>0.05)。两组患者术中均未额外行止血手术。传统手术组患者术后胰液漏、肺部感染、腹腔感染、术后7 d门静脉血栓、住院时间分别为2例、1例、1例、16例、(9.5±1.4)d,改良手术组上述指标分别为1例、0、0、15例、(9.3±1.4)d。两组患者胰液漏、肺部感染、腹腔感染比较,差异均无统计学意义(P>0.05);术后7 d门静脉血栓、住院时间比较,差异均无统计学意义(χ^2=0.123,t=-0.821,P>0.05)。术后发生并发症的患者均经对症支持治疗后好转。两组患者术后均无切口和胃瘘相关并发症发生。(2)随访情况:两组患者均获得术后随访,随访时间均为12个月。随访期间34例传统手术组患者中胃潴留、腹泻、腹胀、消化道再出血发生例数分别为31、25、27、3例,35例改良手术组患者上述指标分别为3、3、4、4例,两组患者消化道再出血比较,差异无统计学意义(P>0.05);上述其他指标比较,差异均有统计学意义(χ^2=47.083,30.180,32.215,P<0.05)。传统手术组患者术后12个月白蛋白(Alb),术后1个月食管静脉内径分别为(44±5)g/L,(7.4±3.0)mm;改良手术组上述指标分别为(49±3)g/L,(7.7±2.7)mm。两组患者术后12个月Alb比较,差异有统计学意义(t=5.365,P<0.05);术后1个月食管静脉内径比较,差异无统计学意义(t=0.483,P>0.05)。结论改良保留迷走神经腹腔镜脾切除联合贲门周围血管离断术治疗肝硬化门静脉高压症安全、可行,可简易手术流程,缩短手术时间,有效降低消化系统相关并发症的发生,改善患者生命质量。临床试验注册:在美国临床试验数据库(ClinicalTrials.gov)注册,注册号为NCT03396796。

Objective To investigate the clinical efficacy of modified vagus nerve⁃preserving laparoscopic splenectomy and azygoportal disconnection(MVLSD)versus conventional laparoscopic splenectomy and azygoportal disconnection(CLSD)for cirrhotic portal hypertension.Methods The prospective randomized controlled study was conducted.The clinicopathological data of 70 patients with cirrhotic portal hypertension who were admitted to Clinical Medical College of Yangzhou University from April 2018 to February 2019 were collected.Patients were divided into two groups based on a random table.Patients undergoing CLSD were allocated into conventional group,and patients undergoing MVLSD were allocated into modified group,respectively.Observation indicators:(1)intraoperative and postoperative situations;(2)follow⁃up.Follow⁃up was conducted by telephone interview,outpatient and inpatient examination.Patients were followed up once every 3 months to detect upper digestive rebleeding,gastric retention,postprandial fullness and diarrhea.Electronic gastroscopy was performed on patients at postoperative 1,6,12 months.Endoscopic variceal ligation was made if the diameter of the esophageal varices was>5 mm.The follow⁃up was up to February 2020.Measurement data with normal distribution were represented as Mean±SD,and comparison between groups was analyzed using the t test.Measurement data with skewed distribution were represented as M(range).Count data were described as absolute numbers,and comparison between groups was analyzed using the chi⁃square test or Fisher exact probability.Results A total of 70 patients with cirrhotic portal hypertension were selected for eligibility,including 51 males and 19 females,aged(52±12)years,with a range from 22 to 78 years.There were 35 and 35 patients in conventional group and modified group,respectively.One patient withdrew from the study.(1)Intraoperative and postoperative situations:operation time,volume of intraoperative blood loss,cases with intraoperative transfusion,cases with conversion to open laparotomy were(160±26)minutes,(76±104)mL,0,1 of the conventional group,versus(135±27)minutes,(65±68)mL,1,0 of the modified group,respectively.There was a significant difference in the operation time between two groups(t=-3.946,P<0.05).There was no significant difference in the volume of intraoperative blood loss between the two groups(t=-0.562,P>0.05),and there was also no significant difference in the intraoperative blood transfusion or conversion to laparotomy between the two groups(P>0.05).Neither group had emergency operation for bleeding.Caes with postoperative pancreatic fistula,pulmonary infection,abdominal infection and cases with portal vein thrombosis during postoperative 7 days,duration of hospital stay were 2,1,1,16,(9.5±1.4)days of the conventional group,versus 1,0,0,15,(9.3±1.4)days of the modified group,respectively.There was no significance difference in the postoperative pancreatic fistula,pulmonary infection or abdominal infection between two groups(P>0.05).There was no significant difference in the portal vein thrombosis or duration of hospital stay between the two groups(χ^2=0.123,t=-0.821,P>0.05).Patients with postoperative complications were cured after symptomatic and support treatment.No incision complication or gastric fistula occurred in either group.(2)Follow⁃up:all patients were followed up for 12 months.During the follow⁃up,gastric retention,diarrhea,abdominal distension and gastrointestinal rebleeding occurred in 31,25,27 and 3 of 34 patients in the conventional group,and the above complications occurred in 3,3,4 and 4 of 35 patients in the modified group,respectively.There was no significant difference in the gastrointestinal rebleeding between two groups(P>0.05).There were significant differences in the gastric retention,diarrhea or abdominal distension between two groups(χ^2=47.083,30.180,32.215,P<0.05).The albulin level at postoperative 12 months and esophageal varices diameter at postoperative 1 month were(44±5)g/L and(7.4±3.0)mm of the conventional group,versus(49±3)g/L and(7.7±2.7)mm of the modified group,respectively.There was a significant difference in the albulin level at postoperative 12 months between the two groups(t=5.365,P<0.05),while there was no significant difference in the esophageal varices diameter at postoperative 1 month(t=0.483,P>0.05).Conclusion MVLSD is a technically feasible and safe procedure in the treament of cirrhotic portal hypertension,which can not only simplify the process and shorten operation time,but also effectively reduces postoperative digestive system complications and improve quality of life.Trial Registration:this study was registrated at ClinicalTrial.gov in United States with the registration number of NCT03396796.