单人经口胆道镜系统直视下与传统X线下非困难性胆总管结石取石的对比研究

Comparison of stone extraction under direct visualization with a single peroral choledochoscopy system and conventional X-ray endoscopic retrograde cholangiopancreatography for non-difficult common bile duct stones

目的比较单人经口胆道镜系统直视下取石与传统X线下内镜逆行胰胆管造影术(endoscopic retrograde cholangiopancreatography,ERCP)取石治疗非困难性胆总管结石的有效性和安全性。方法纳入2018年1月—2022年4月在北京中医药大学东方医院使用单人经口胆道镜系统直视下取石(观察组)及传统X线下内镜逆行胰胆管造影术(endoscopic retrograde cholangiopancreatography,ERCP)取石(对照组)的胆总管结石患者各82例。观察组由数据库直接筛选所得,对照组按年龄分层随机匹配所得,并验证基线数据。比较两组的插管成功率、取石成功率、术后并发症发生率、放射射线曝光量。结果观察组及对照组基线数据差异均无统计学意义(P>0.05)。观察组结石数量≥2枚的检出例数[59例(71.95%)]高于对照组[37例(45.12%)],差异有统计学意义(χ^(2)=12.16,P=0.001)。观察组和对照组胆管插管成功率均为100.00%(82/82);取石成功率分别为98.78%(81/82)和100.00%(82/82),差异无统计学意义(P>0.05);一次取净结石率分别为93.90%(77/82)和92.68%(76/82),差异无统计学意义(χ^(2)=0.10,P=0.755)。观察组与对照组术后并发症发生率差异无统计学意义(P>0.05)。在术中射线曝光量方面,观察组为10.20(6.69,18.94)mGy,对照组为15.41(10.70,22.77)mGy,观察组术中射线曝光量显著低于对照组(U=2462.00,P=0.003)。结论单人经口胆道镜系统直视下取石与传统X线下ERCP取石治疗非困难性胆总管结石的有效性和安全性相当,但能够显著降低治疗性ERCP取石过程中的辐射量。

Objective To compare the efficacy and safety of stone extraction with a single peroral choledochoscopy system under direct visualization and conventional X-ray endoscopic retrograde cholangiopancreatography(ERCP)for non-difficult common bile duct stones.Methods A total of 164 patients with common bile duct stones who underwent stone extraction by using the single peroral choledochoscopy system under direct visualization(the observation group,n=82)and conventional X-ray endoscopic retrograde cholangiopancreatography(ERCP)(the control group,n=82)from January 2018 to April 2022 in Dongfang Hospital,Beijing University of Chinese Medicine were enrolled.The observation group was directly selected from the database,while the control group was randomly matched by age stratification with baseline data validated.The success rates of intubation,stone removal,postoperative complication incidence,and radiation exposure between the two groups were compared.Results There was no significant difference between the baseline data of the observation group and the control group(P>0.05).The number of patients with detected stones≥2 in the observation group and the control group were 59(71.95%)and 37(45.12%)respectively with significant difference(χ^(2)=12.16,P=0.001).The success rates of bile duct intubation in the observation group and the control group were both 100.00%(82/82).The success rates of stone extraction were 98.78%(81/82)and 100.00%(82/82)respectively with no significant difference(P>0.05).The one-time stone removal rates of the two groups were 93.90%(77/82)and 92.68%(76/82)respectively with no significant difference(χ^(2)=0.10,P=0.755).There was no significant difference in the incidence of postoperative complications between the observation group and the control group(P>0.05).The amount of intraoperative ray exposure volume in the observation group was significantly lower than that of the control group[10.20(6.69,18.94)mGy VS 15.41(10.70,22.77)mGy,U=2462.00,P=0.003].Conclusion The efficacy and safety of stone extraction with single peroral choledochoscopy system under direct visualization are comparable to those of traditional X-ray ERCP for non-difficult common bile duct stones,but it can significantly reduce the intraoperative ray exposure volume during therapeutic ERCP stone extraction.