Endoscopic Papillary Large Balloon Dilation Reduces Further Recurrence in Patients With Recurrent Common Bile Duct Stones: A Randomized Controlled Trial
Endoscopic Papillary Large Balloon Dilation Reduces Further Recurrence in Patients With Recurrent Common Bile Duct Stones: A Randomized Controlled Trial
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DOI：
10.14309/ajg.0000000000001690
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发表时间：
2022-02
期刊：
影响因子：
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通讯作者：
Xu Wang;Xiangping Wang;Hao Sun;Gui Ren;Biao-luo Wang;Shuhui Liang;Linhui Zhang;Xiaoyu Kang;Qin Tao;Xuegang Guo;Hui Luo;Yanglin Pan
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作者：
Xu Wang;Xiangping Wang;Hao Sun;Gui Ren;Biao-luo Wang;Shuhui Liang;Linhui Zhang;Xiaoyu Kang;Qin Tao;Xuegang Guo;Hui Luo;Yanglin Pan
简介：胆总管结石（CBDS）复发的患者中，高达60%的患者在内镜逆行胰胆管造影（ERCP）后会再次复发。大多数患者没有有效的方法来预防复发。在这项研究中，我们的目的是在一项随机对照试验中评估内镜下乳头状大球囊扩张术（EPLBD）治疗复发性CBDS的短期和长期疗效。方法：符合条件的CBDS复发患者按1：1的比例随机分为EPLBD组或对照组。主要结局是ERCP后2年内CBDS复发率。分析遵循意向治疗原则。结果：从2014年到2021年，180例复发性CBDS患者被纳入，每组90例。所有患者均通过1次或多次ERCP完全清除了CBDS。EPLBD治疗组1次治疗的完全清除率显著较高（95.6% vs 85.6%，P = 0.017）。随访期间，EPLBD组2年内CBDS复发率显著低于对照组（21.1% [19/90] vs 36.7% [33/90]，相对风险0.58，95%可信区间0.36-0.93，P = 0.021）。在中位随访约56个月时，EPLBD组34.4%（31/90）的患者和对照组51.1%（46/90）的患者发生CBDS复发（风险比0.57，95%置信区间0.36-0.89，P = 0.012）。EPLBD组的多次复发（≥2次）也减少（4.4% vs 18.9%，P = 0.020）。讨论：在长期随访中，近一半的复发性CBDS患者在传统ERCP后出现结石复发。我们的研究首次表明EPLBD有效地降低了CBDS的复发。
INTRODUCTION: Up to 60% of patients with common bile duct stone (CBDS) recurrence suffer from further recurrence after endoscopic retrograde cholangiopancreatography (ERCP). There are no effective methods to prevent recurrence in most patients. In this study, we aimed to assess the short-term and long-term efficacies of endoscopic papillary large balloon dilation (EPLBD) for the management of recurrent CBDS in a randomized controlled trial. METHODS: Consecutive patients with recurrent CBDS were eligible and randomly assigned in a 1:1 ratio to the EPLBD group or the control group. The primary outcome was the CBDS recurrence rate within 2 years after ERCP. The analysis followed the intention-to-treat principle. RESULTS: From 2014 to 2021, 180 patients with recurrent CBDS were included, with 90 in each group. All patients underwent complete CBDS clearance by 1 or several sessions of ERCP. The rate of complete clearance in 1 session was significantly higher with EPLBD treatment (95.6% vs 85.6%, P = 0.017). During the follow-up, the CBDS recurrence rate within 2 years was significantly lower in the EPLBD group than in the control group (21.1% [19/90] vs 36.7% [33/90], relative risk 0.58, 95% confidence interval 0.36–0.93, P = 0.021). At a median follow-up of approximately 56 months, CBDS recurrence was found in 34.4% of the patients (31/90) in the EPLBD group and 51.1% (46/90) in the control group (hazard ratio 0.57, 95% confidence interval 0.36–0.89, P = 0.012). Multiple recurrences (≥2) were also decreased in the EPLBD group (4.4% vs 18.9%, P = 0.020). DISCUSSION: During the long-term follow-up, nearly half of the patients with recurrent CBDS experienced stone recurrence after traditional ERCP. Our study was the first to show that EPLBD effectively reduced the recurrence of CBDS.