A Prospective Randomized Controlled Clinical Study Of Minimally Invasive Treatment Of Small And Medium-sized Calculi Of Common Bile Duct Complicated With Cholecystolithiasis

Objective: To compare the surgical differences among endoscopic retrograde cholangiopancreatography(ERCP)+Endoscopic na sobiliary drainage(ENBD)(or Endoscopic Retrograde Biliary Drainage ERBD)+laparoscopic cholecystectomy(LC)“Two-step method”,Laparo-scopic cholecystectomy comined laparoscopic common bile duct stones exploration+intraoperative choledochoscope+primary suture of common bile duct or T-tube drainage“one-step method”,and diagnosing ERCP+ Endoscopic Papillary Balloon Dilatation+ENBD+LC+LCBDE+intraoperativ e choledochoscope+primary suture of common bile duct(DEPELIP)“New two-step method”,so as to provide evidence-based medical evidence for stand-ardized treatment on cholecystolithiasis with small and medium-sized gallstones within a diameter of less than 1.0 cm.Methods:This study was a prospective,randomized controlled study.Seventy-seven patients with cholecystolithiasis complicated with small and medium-sized calculi of common bile duct hospitalized and treated in the Second Affiliated Hospital of Guangzhou Medical University from September 2018 to April 2020 were enrolled and randomized into groups: 31 in“Two-step method”group,19 in “One-step method”group,and 27 in “New two-step method method”group.Hospitalization cost,hospital stays,operation time,success rate of surgery,net stone rate,intraoperative bleeding,short-term and long-term complications,postoperative pain score,patient satisfaction,blood routine and liver and kidney function and other related indicators on the 1st,3rd and 5th days after operation were compared among the above three methods.Results:Totally 77 patients are enrolled in this study,including 31 in“Two-step method”group,19 in “One-step method”group,and 27 in “New two-step method method”group.In the “Two-step method”group,one patient withdrew from the study due to the Mirizzi Syndrome during ERCP,while the remaining 76 completed the study.Compared with 23 items of preoperative data of patients in the three groups,the P > 0.05,showing no statistical significance.The ERCP+LC group is better than the other two groups in terms of operation time and hospitalization duration,with P < 0.05,which was statistically significant.The operative time(minutes)of the three groups were as follows: “Two-step method”group(120.57±24.78),“One-step method”group(133.26 ± 27.84),“ New two-step method ” group(140.63 ± 21.07).The hospitalization duration(day)were:“Two-step method”group(10.27±2.83),“One-step method”group(12.84±2.89),“New two-step method” group(14.04±4.17).The hospitalization costs(yuan)of LC+LCBDE group were lower than other two groups,which were:“Two-step method”group(66162.71±9315.21),“One-step method”group(52739.01±10908.17),“New two-step method”group(67323.42±11898.56),with P= 0.001,which was statistically significant.The VAS score of 3h and 24 h after ERCP and 3h after laparoscope in the “ Examining ERCP+balloon dilatation+ENBD +LC+ LCBDE+intraoperative choledochoscope+primary suture of common bile duct”group were better than those in the other two groups.The VAS score of 3h after ERCP were:“Two-step method”group(1.63±0.72),“New two-step method” group(1.19±0.48).The VAS score of 24 h after ERCP were:“Two-step method”group(1.20±0.45),“New two-step method” group(1.07±0.67).The VAS score of 3h 3h after laparoscope were:“Two-step method”group(1.83±0.95),“One-step method”group(2.74±1.24),“New two-step method” group(2.07±0.78),with P<0.05,which was statistically significant.Secondly,the trauma of “New two-step method” group was smaller than the other two groups in the postoperative Hb and the decrease of postoperative ALB.On the first day after operation,Hb(g/L)situation was as follows:“Two-step method”group(4.40±4.68),“One-step method”group(6.68±8.61),“New two-step method” group(1.33±5.92);And ALB(g/L)situation was:“Two-step method”group(4.34±4.37),“One-step method”group(8.90±1.9),“New two-step method” group(2.43±3.5).Data was statistically significant with P<0.05.Conclusion:1.ERCP+LC、LC+LCBDE、DEPELIP are all effective in the treatment of gallbladder stones combined with bile duct stones.2.LC+LCBDE is a classic treatment of gallbladder stones combined with bile duct stones.This study shows that it has lower hospitalization expense and a high success rate relatively.It can be used as the first choice for adol-escents who need to retain the function of sphincter of Oddi’s,patients with reconstruction of digestive system and patients with bile duct stones > 2cm in diameter and hepatolith.Primary bile duct suture is recommended for patients who meet primary suture criteria.Patients with a common bile duct diameter less than 8mm should be considered with caution.3.As one of the mainstream surgery,This study shows that ERCP+LC can shorten the time of hospital stay and accelerate the recovery after operation.It can be used as the first choice for elderly patients with serious condition,coagulation disorders,complicated with biliary pancreatitis,acute obstructive supputative cholangitis and poor cardiopulmonary function.It should be carefully considered to adolescent patients because of its permanent damage to the function of Oddi’s sphincter.4.As a new surgical method,DEPELIP has excellent performance in surgical efficacy and safety.It was significantly better than the other two groups especially in postoperative pain and stress trauma,which is worthy of popularization and application.5.Factors of stone recurrence:common bile duct diameter>12mm,multiple common bile duct stones,sandy stones,parapapillary diverticulum are high risk factors of stone recurrence.The fact that diameter of common bile duct>12m is an independent risk factor for postoperative recurrence of common bile duct stones...