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.

Methods

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.

Results

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).

Conclusions

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.

中文翻译：

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随机试验中单人胆管镜引导碎石术与大球囊括约肌成形术治疗困难胆管结石的疗效比较。

背景与目标

尽管单操作者胆管镜 (SOC) 引导的碎石术和基于大球囊括约肌成形术 (LBS) 的技术是有效的抢救措施，但治疗困难胆管结石的理想方法尚不清楚。我们进行了一项随机试验，以比较 SOC 引导的碎石术和基于 LBS 的方法对困难胆管结石的内镜治疗的有效性。

方法

从 2016 年 6 月到 2018 年 8 月，使用球囊或篮子取出失败的胆管结石患者被随机分配到接受 SOC 引导的激光碎石术 (SOC-LL, n = 33) 或 LBS (n = 33) 的组。分配的治疗不成功，患者在转移到另一组之前接受了机械碎石术。主要结果是治疗成功，定义为在 1 次治疗中清除导管的能力。次要结果是不良事件和治疗费用。

结果

SOC-LL 组的治疗成功率 (93.9%) 高于 LBS 组 (72.7%；P  = .021)。在多元逻辑回归分析中，治疗成功与 SOC-LL 的使用显着相关（优势比 [OR]，8.7；95% CI，1.3-59.3；P  = .026 ），结石与肝外胆管的比率为 1 或更低(OR, 28.8; 95% CI, 1.2–687.6; P  = .038 ), 并且没有锥形胆管 (OR, 26.9; 95% CI, 1.3–558.2; P  = .034 )。在不良事件（SOC-LL 组为 9.1% 对 LBS 组为 3.0%，P  = .61）或总体治疗成本（SOC-LL 组为 16,684 美元对 LBS 组为 10,626 美元）方面，各组之间没有显着差异; P  = .097）。

结论

在一项针对标准操作无法清除的困难胆结石患者的随机试验中，SOC 引导的碎石术导致胆管清除率显着高于 LBS，尤其是当结石大小超过肝外胆​​管直径时。远端胆管呈锥形的患者可能需要辅助碎石术，因为单独的 LBS 不太可能成功。ClinicalTrials.gov 编号：NCT00852072。