Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.
Center for Interventional Endoscopy, AdventHealth Orlando, Orlando, Florida.
Clin Gastroenterol Hepatol. 2020 Sep;18(10):2349-2356.e3. doi: 10.1016/j.cgh.2020.02.003. Epub 2020 Feb 10.
BACKGROUND & AIMS: Although single-operator cholangioscopy (SOC)-guided lithotripsy and large balloon sphincteroplasty (LBS)-based techniques are effective rescue measures, the ideal approach to management of difficult bile duct stones is unclear. We conducted a randomized trial to compare the effectiveness of SOC-guided lithotripsy and LBS-based approaches for endoscopic management of difficult bile duct stones.
Patients with difficult bile duct stones who failed retrieval using balloon or basket were randomly assigned to groups that received SOC-guided laser lithotripsy (SOC-LL, n = 33) or LBS (n = 33), from June 2016 through August 2018. When assigned treatment was unsuccessful, patients underwent mechanical lithotripsy before crossing over to the other group. The main outcome was treatment success, defined as ability to clear the duct in 1 session. Secondary outcomes were adverse events and treatment costs.
A higher proportion of patients in the SOC-LL group had treatment success (93.9%) than in the LBS group (72.7%; P = .021). On multiple logistic regression analysis, treatment success was significantly associated with use of SOC-LL (odds ratio [OR], 8.7; 95% CI, 1.3-59.3; P = .026), stone to extrahepatic bile duct ratio of 1 or less (OR, 28.8; 95% CI, 1.2-687.6; P = .038), and lack of a tapered bile duct (OR, 26.9; 95% CI, 1.3-558.2; P = .034). There was no significant difference between groups in adverse events (9.1% in the SOC-LL group vs 3.0% in the LBS group, P = .61) or overall treatment cost ($16,684 in the SOC-LL group vs $10,626 in the LBS group; P = .097).
In a randomized trial of patients with difficult bile stones that cannot be cleared by standard maneuvers, SOC-guided lithotripsy leads to duct clearance in a significantly higher proportion of patients than LBS-particularly when stone size exceeds the diameter of the extrahepatic bile duct. Adjunct lithotripsy might be required in patients with tapered distal bile duct, because LBS alone is less likely to be successful. ClinicalTrials.gov no: NCT00852072.
虽然单操作员胆管镜检查（SOC）引导下的碎石术和大球囊扩张术（LBS）为有效的补救措施，但对于困难胆管结石的理想治疗方法尚不清楚。我们进行了一项随机试验，比较 SOC 引导下碎石术和 LBS 为基础的技术治疗困难胆管结石的有效性。
2016 年 6 月至 2018 年 8 月，使用球囊或篮筐取石失败的困难胆管结石患者被随机分为 SOC 引导下激光碎石术（SOC-LL，n=33）或 LBS 组（n=33）。当指定的治疗方法不成功时，患者在交叉到另一组之前接受机械碎石术。主要结局是治疗成功，定义为 1 次治疗清除胆管。次要结局为不良事件和治疗费用。
SOC-LL 组的治疗成功率（93.9%）高于 LBS 组（72.7%；P=0.021）。多元逻辑回归分析显示，SOC-LL 的使用与治疗成功率显著相关（优势比[OR]，8.7；95%CI，1.3-59.3；P=0.026），结石与肝外胆管的比值为 1 或更小（OR，28.8；95%CI，1.2-687.6；P=0.038），胆管无锥形（OR，26.9；95%CI，1.3-558.2；P=0.034）。两组间不良事件（SOC-LL 组 9.1%，LBS 组 3.0%，P=0.61）或总体治疗费用（SOC-LL 组 16684 美元，LBS 组 10626 美元；P=0.097）无显著差异。
在一项标准操作无法清除的困难胆管结石患者的随机试验中，SOC 引导下碎石术导致胆管清除的成功率显著高于 LBS 组-特别是当结石大小超过肝外胆管直径时。对于远端胆管呈锥形的患者，可能需要辅助碎石术，因为单独使用 LBS 不太可能成功。临床试验.gov 编号：NCT00852072。
