| BackgroundHepatolithiasis refers to stones that originate in the intrahepatic bile duct system.It can be present alone or in combination with extrahepatic bile duct stones.It is common in Southeast Asia.The southwestern and Yangtze River basins of China are high-risk areas.Epidemiological surveys show that the incidence rate in high-incidence areas is 10-20%,especially in rural and remote areas,and its incidence accounts for 38.0% to 55.8% of the total cholelithiasis.Hepatolithiasis is often associated with varying degrees of biliary and hepatocyte damage,causing serious complications such as atrophic-proliferative syndrome,biliary cirrhosis,portal hypertension,end-stage biliary disease,and even cancer.Due to complicated conditions,high residual and re-operation rate of stone,hepatolithiasis is the leading cause of death in benign biliary diseases in China.Hepatolithiasis is rare in Europe and America.In recent years,due to factors such as immigration,there have been cases reported in European and American countries.However,they are relatively simple to treat because most of them are regional stones with milder conditions.There is little research on the diagnosis and treatment experience and pathogenesis of complex hepatolithiasis.The treatment of hepatolithiasis is mainly surgery.Traditional open surgery was once considered the standard procedure for the treatment of hepatolithiasis.Open surgery has a large trauma and slow recovery after surgery.Patients with hepatolithiasis who have undergone multiple operations have severe abdominal adhesions and difficulty in displaying the hilar area.It is difficult to perform surgery on such patients,and the risk of complications is high.Minimally invasive surgery such as laparoscopy has the advantages of less trauma and quick recovery after surgery.Its application in regional hepatolithiasis is increasing.Our center has carried out laparoscopic liver resection for more than ten years.We have accumulated a large number of case data,and the surgical technique has gradually matured.In recent years,the robotic surgery system has been introduced into the clinic,which is superior to traditional laparoscopy in terms of visual field stability and fine operation.It has expanded the indications for laparoscopic surgery and raised the precision of minimally invasive surgery to a new level.Theoretically,complicated hepatolithiasis with hepatic hilar transposition or bile duct stricture can be completed by robot-assisted laparoscopic surgery,but there are few reports.To further clarify the safety,feasibility and effectiveness of laparoscopic and robotic surgery for hepatolithiasis,we retrospectively analyzed the clinical data of minimally invasive surgery and open surgery for hepatolithiasis.Case selection and inter-group confounding bias were reduced by Propensity Score Matching(PSM).Analyze and compare the difference between the efficacy of laparoscopic and robotic minimally invasive surgery and open surgery,and provide evidence-based medical evidence for the selection of minimally invasive treatment for different types of hepatolithiasis.This study is divided into two parts.The first part collects the clinical data of laparoscopic and open surgery for hepatolithiasis from the First Affiliated Hospital of Army Military Medical University from 2013 to 2018.According to the stratified comparison of regional and complex types,the general data,perioperative results and long-term efficacy between laparoscopic and open surgery groups were statistically analyzed.The second part explores and establishes the technical method of robotic surgery for hepatolithiasis by analyzing the efficacy of robotic and open surgery in the treatment of complicated hepatolithiasis.The study was approved by the Ethics Committee of the First Affiliated Hospital of the Army Military Medical University(Approval No.: 2017 Scientific Research No.(28)).Registration has been completed on the International Clinical Research website(Clinical Trails.gov)(Registration No.: NCT03297099).It was funded by the National Health Commission’s special project on scientific research for the public health-Establishment of the Code for Surgical Treatment of hepatolithiasis(201502014).MethodPart I: Cases of laparoscopic or open surgery were performed in the Department of Hepatobiliary Surgery,the First Affiliated Hospital of the Army Military Medical University from January 2013 to October 2018.A total of 403 cases of regional hepatolithiasis and 288 cases of complicated hepatolithiasis were collected.Among them,regional hepatolithiasis included 160 cases of laparoscopic surgery and 243 cases of open surgery.Complicated hepatolithiasis included 38 cases of laparoscopic surgery and 250 cases of open surgery.The PSM method was used to reduce the confounding bias.The regional hepatobiliary disease was matched by 1:1,and the complicated hepatolithiasis was 1:2.A total of 296 patients were successfully matched.Among them,regional hepatolithiasis: 91 cases in laparoscopic(LS-RHL group)and 91 cases in open surgery(OS-RHL group).Complex hepatolithiasis: 38 cases of laparoscopic(LS-CHL group)and 76 cases of open surgery(OS-CHL group).The demographic data,perioperative outcomes,and recurrence of stones and cholangitis was analyzed.Part II: From October 2010 to August 2017,a total of 26 patients with complicated hepatolithiasis(RLS group)underwent robotic surgery in our hospital.287 cases of complicated hepatolithiasis were treated with open surgery at the same time.Using the PSM method,52 patients were matched from the 287 patients in the open surgery group(OS group)according to the ratio of 1:2.Perioperative results and follow-up data were analyzed.ResultPart I: There were significant differences in demographic data between 198 laparoscopic and 493 open surgery groups.There was no significant difference in the baseline data between the LS-RHL group and the OS-RHL group,the LS-CHL group and the OS-CHL group,and the comparability was good.For regional hepatolithiasis,laparoscopic surgery group has less blood bleeding(238.57 ± 148.32 vs 346.15 ± 204.16 ml,p = 0.000),early recovery after surgery(3.80 ± 1.26 vs 4.46 ± 1.84 Days,p=0.005),shorter postoperative hospital stay(9.51±2.67 vs 14.75±3.32 days,p=0.000)compared with open surgery group,and the differences is statistically significant.At the same time,compared with open surgery,laparoscopic surgery has certain advantages in terms of calculi clearance rate during surgery(89(97.80%)vs 84(92.31%),p=0.171),postoperative complication rate(13.19% vs 15.38%,p=0.672)),operation time(256.23±86.66 vs 279.53±100.77),final stone clearance rate(91(100.00%)vs 86(94.51%),p=0.070),stone recurrence rate(2(2.20%)vs 6(6.59%),p=0.278),and cholangitis recurrence rate(5(5.49%)vs 9(9.89%),p=0.266),while there was no significant statistically difference between two groups.For complex hepatolithiasis,laparoscopic surgery is superior to traditional open surgery in postoperative recovery data,but the statistical difference is not obvious.In the laparoscopic surgery,11 cases were converted to open surgery,and the conversion rate was 28.95%.The laparoscopic group had a slightly longer operation time than the open group(386.08±119.87 vs 378.75±121.01,p=0.76),and the range of intraoperative bleeding fluctuations was large(500(300-825)vs 500(312.5-675)ml,p=0.609.The intraoperative blood transfusion rate(36.84% vs 35.53%,p=0.890)and the postoperative complication rate(55.26% vs 52.63%,p=0.791)were slightly higher,but the differences were not statistically significant.There was no significant difference in the recurrence rate of stones and the recurrence rate of cholangitis in the two groups.Part II: For complicated hepatolithiasis,the robot-assisted laparoscopic surgery system has less intraoperative blood loss(315.38±237.81 vs 542.88±518.70 ml,p=0.037)and lower transfusion rate(4)./26 15.4% vs 24/52 46.2%,p=0.008),faster recovery after surgery(3.50±1.30 vs 5.88±4.00 days,p=0.004),postoperative hospital stay was shorter(13.54±6.54 vs 17.81±7.49 days),p = 0.016),the difference between groups is more obvious.However,the robotic group had a longer operation time(376.69±129.05 vs 319.15±127.58 min,p=0.065),and the total hospitalization cost was higher(106673.97±31492.45 vs 85207.57±37601.79 RMB,p=0.014).There were no significant differences in intraoperative stone clearance,final stone clearance,postoperative complication rate,stone recurrence rate,and recurrent cholangitis.Conclusion1.Laparoscopic surgery for regional hepatolithiasis is safe and feasible,and the curative effect is exact.It has the advantages of less intraoperative blood loss,earlier recovery after surgery,and shorter hospital stay.The long-term curative effect of stone removal rate and stone recurrence rate is equivalent to open surgery.It can be used as the first choice for regional hepatolithiasis.2.For complex hepatolithiasis,there are fewer cases of laparoscopic surgery.Preliminary results indicate that postoperative recovery is relatively fast.However,there is a higher rate of conversion to open surgery,and the overall efficacy has no obvious advantage compared with open surgery.It is suggested that laparoscopic treatment of complicated hepatolithiasis is still in the technical exploration stage.3.Robotic surgical systems are safe and feasible for the treatment of complex hepatolithiasis.It is superior to open surgery in intraoperative blood transfusion rate,postoperative recovery and postoperative hospital stay,and achieves the same long-term efficacy as open surgery.It opens up a new way for minimally invasive treatment of complicated hepatolithiasis.However,Due to the high cost and other factors,the application of robotic surgery system is limited to a certain extent.4.This study was a large sample case-control study of minimally invasive treatment of hepatolithiasis,using PSM to reduce case selection bias to achieve a prospective effect.It provides a higher level of medical evidence for the selection of surgical procedures for different types of hepatolithiasis.However,in this study,laparoscopic and robotic surgery for complex hepatolithiasis is relatively rare.Further multi-center,large-sample prospective randomized controlled trials are needed. |
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