| Purpose:Gallbladder stones combined with choledocholithiasis are one of the most common diseases of the biliary system.Stones staying in the biliary system can hinder the excretion of bile and at the same time create favorable conditions for bacteria to multiply in the biliary tract.Stones in the biliary tract can induce a series of acute inflammations,which seriously threaten human health.In the era of minimally invasive surgery,in the face of diseases such as gallbladder stones and common bile duct stones,there are two main clinically popular minimally invasive procedures.The first is laparoscopic cholecystectomy combined with common bile duct incision and exploratory lithotripsy,namely LC+ LCBDE;The second type of operation is laparoscopic cholecystectomy combined with endoscopic retrograde cholangiopancreatography/choledocholithotomy/endoscopic papillary sphincterotomy,namely LC+ERCP/EST.In the face of the choice of these two mainstream surgical procedures,there is no uniform standard at home and abroad.In order to explore the pros and cons of the two surgical procedures for patients with gallbladder stones and common bile duct stones,the author uses Meta analysis to evaluate the effectiveness and safety of the two surgical procedures.,And then provide more reference basis for this type of patients in the choice of surgical treatment.On the other hand,this study estimated the number of samples needed to draw a positive conclusion by comparing the two surgical stone clearance rates through trial sequential analysis(TSA),that is,the expected amount of information(RIS).By comparing the total sample size accumulated by the Meta analysis with the expected amount of information,it can be concluded whether researchers need to stop this type of randomized controlled trial study(RCT),which can avoid the waste of scientific research and medical resources.Methods: Computer search in Pubmed/Medline,Embase,Cochrane Library,CBM,Google Scholar,China Knowledge Network(CNKI),Weipu,Wanfang and other databases and clinical trial registration websites at home and abroad from the establishment of the database to December 2020 All Chinese and English clinical randomized controlled trials comparing the effectiveness and safety of the two surgical methods.After collecting the data,use the Review Manager(Rev Man version 5.4)software provided by the Cochrane Collaboration to perform meta-analysis.The trial sequence analysis software issued by the Copenhagen trial unit(CTU)was used to perform trial sequence analysis on the main outcomes of this study.Results: Relevant literatures were retrieved according to key words,and a total of 18 Chinese and English clinical randomized controlled trials were finally included.Using the bias risk assessment system provided by the Cochrane Handbook to carefully evaluate the potential risk of bias of each RCT,it was found that 9 studies had a high risk of bias and 9 studies had an uncertain risk of bias.In 18 RCTs,2168 patients with gallbladder stones and choledocholithiasis were included.Among them,1089 patients received LC+LCBDE surgery,and 1079 patients received LC+ERCP/EST surgery.According to the comparison results of various indicators,the effectiveness and safety of the two surgical procedures are evaluated,so as to provide relevant reference basis for the selection of clinical procedures.This meta-analysis showed that the stone clearance rate of patients receiving the LC+ERCP/EST surgery was 90.3%,and that of patients receiving the LC+LCBDE surgery was 89.9%,[OR 1.06,95%CI(0.80,1.41),P=0.69],it is suggested that there is no statistically significant difference between the two surgical methods in the comparison of the stone clearance rate;The incidence of abdominal infection after LC+ERCP/EST surgery was 2.4%,and the incidence of abdominal infection after LC+LCBDE surgery was 4.2%,[ OR 0.55,95%CI(0.29,1.07),P=0.08 ],it suggests that there is no statistically significant difference in abdominal infection between the two surgical procedures;The postoperative mortality rate of the LC+ERCP/EST surgical program is about 1%,and the postoperative mortality rate of the LC+LCBDE surgical program is 3‰,[ OR 2.56,95%CI(0.59,11.07),P=0.21 ],the difference was not statistically significant;The conversion to laparotomy rate of LC+ERCP/EST surgery was 3.4%,and the conversion to laparotomy rate of LC+LCBDE surgery was5.8%,[ OR 0.60,95%CI(0.35,1.03),P=0.06 ],the difference was not statistically significant;The incidence of biliary leakage after LC+ERCP/EST surgery was 0.8%,and the incidence of biliary leakage after LC+LCBDE surgery was 5.6%,[ OR0.21,95%CI(0.11,0.40),P<0.00001 ],the difference was statistically significant;The incidence of pancreatitis after LC+ERCP/EST surgery was 5.2%,and the incidence of pancreatitis after LC+LCBDE surgery was 0.5%,[ OR 5.33,95%CI(2.69,10.58),P<0.00001 ],the difference was statistically significant;The incidence of biliary hemorrhage after LC+ERCP/EST surgery was 3.2%,and the incidence of biliary hemorrhage after LC+LCBDE surgery was 0.4%,[ OR 4.16,95%CI(1.90,9.08),P=0.0003 ],the difference was statistically significant.The sequential analysis of the trial showed that the expected information volume of the study on the stone clearance rate was 1036 cases,and the cumulative number of study samples from the included 18 clinical randomized controlled trials was 2168,which exceeded the expected information volume estimated by the TSA,but The cumulative Z-score curve does not cross the traditional and TSA thresholds.It can be considered that the LC+LCBDE and LC+ERCP/EST methods have no statistical difference in the stone clearance rate of patients with choledocholithiasis and choledocholithiasis,and There is no need to conduct similar related RCT comparative studies in clinical practice.Conclusion: The results of this meta-analysis study show that the two surgical methods have the same stone clearance rate;the main complication after LC+LCBDE is bile leakage;the main complication after LC+ERCP/EST is pancreatitis;after LC+LCBDE The rate of abdominal infection was greater than that of LC+ERCP/EST;the risk of biliary bleeding after LC+ERCP/EST was greater than that of LC+LCBDE.TSA believes that there is no statistical difference in the related studies on the comparison of the LC+LCBDE and LC+ERCP/EST stone clearance rates,and the sample size of the study has exceeded the expected amount of information. |
