SpyGlass直视下激光碎石术与腹腔镜胆总管探查术治疗胆总管巨大结石的非劣效对照研究

SpyGlass-guided laser lithotripsy versus laparoscopic common bile duct exploration for large common bile duct stones:a non-inferiority trial

目的评价SpyGlass直视下激光碎石术治疗胆总管巨大结石(直径>2 cm)的临床疗效及安全性。方法2015年8月—2018年8月,山东第一医科大学第一附属医院收治的157例胆总管巨大结石患者纳入研究,采用随机数字随机分入SpyGlass组(78例)或腹腔镜胆总管探查术(laparoscopic common bile duct exploration,LCBDE)组(79例),SpyGlass组采用SpyGlass直视下激光碎石术治疗,LCBDE组采用LCBDE治疗。主要观察结石取净率和一次性结石取净率,非劣效检验的非劣效界值设为10%。次要观察指标包括中转率、短期并发症发生率、住院时间、患者生活质量(采用胃肠道生活质量指数评分)。结果结石取净率SpyGlass组和LCBDE组分别为92.3%(72/78)和96.2%(76/79)(P=0.023),非劣效假设成立;一次性结石取净率SpyGlass组和LCBDE组分别为83.3%(65/78)和96.2%(76/79)(P=0.124),非劣效假设不成立。与LCBDE组比较,SpyGlass组中转率略高[7.7%(6/78)比3.8%(3/79),P=0.294],短期并发症总体发生率略低[5.1%(4/78)比10.1%(8/79),P=0.246],住院时间更短[(5.65±0.94)d比(8.84±1.54)d,P=0.001],术后1个月、术后3个月胃肠道生活质量指数评分更高[术后1个月:(99.85±4.36)分比(91.51±5.47)分,P=0.001;术后3个月:(131.24±3.32)分比(112.32±7.77)分,P=0.001]。结论对于胆总管巨大结石,SpyGlass直视下激光碎石的疗效不劣于LCBDE,且更加微创,可作为LCBDE之外的治疗胆总管巨大结石的重要选择。

Objective To evaluate the clinical efficacy and safety of SpyGlass-guided laser lithotripsy for large common bile duct(CBD)stones with diameter>2 cm.Methods From August 2015 to August 2018,a total of 157 patients with large CBD stones at the First Affiliated Hospital of Shandong First Medical University who met the inclusion criteria were randomly divided into SpyGlass group(n=78,underwent SpyGlass-guided laser lithotripsy)and laparoscopic common bile duct exploration(LCBDE)group(n=79,underwent LCBDE)by using random numbers.Non-inferiority test was used for rates of one-time stone removal and total stone removal,and the non-inferiority margin was set to 10%.The transform rate,incidence of short-term complications,hospital stay,and quality of life(assessed by the gastrointestinal quality of life index)were compared between the two groups.Results The total success rates of stone clearance were 92.3%(72/78)and 96.2%(76/79)in the SpyGlass group and LCBDE group,respectively(P=0.023),with valid non-inferiority hypothesis.The one-time stone removal rates were 83.3%(65/78)and 96.2%(76/79),respectively(P=0.124),with invalid non-inferiority hypothesis.There were no significant differences in the incidence of transform[7.7%(6/78)VS 3.8%(3/79),P=0.294]or short-term complications[5.1%(4/78)VS 10.1%(8/79),P=0.246]between the two groups.Compared with the LCBDE group,the SpyGlass group had a shorter hospital stay(5.65±0.94 d VS 8.84±1.54 d,P=0.001)and higher scores of gastrointestinal quality of life index(1 month after operation:99.85±4.36 VS 91.51±5.47,P=0.001;3 months after operation:131.24±3.32 VS 112.32±7.77,P=0.001).Conclusion For large CBD stones,the efficacy of SpyGlass-guided laser lithotripsy is not inferior to LCBDE,and it is less invasive.In the future,SpyGlass-guided laser lithotripsy could be an important option for the treatment of large CBD stones.