Yang Ye, Wang Youhong, Chen Qi, Qiu Jingjing, Zhu Liping
Department of Hepatobiliary Surgery, Wuhan No.1 Hospital (Wuhan Hospital of Traditional Chinese & Western Medicine), No. 215 Zhongshan Road, Qiaokou District, Wuhan, 430030, Hubei, China.
Updates Surg. 2025 Aug 7. doi: 10.1007/s13304-025-02340-9.
The objective of the study was to explore the effectiveness and safety of endoscopic retrograde cholangiopancreatography (ERCP) compared to percutaneous transhepatic biliary drainage (PTBD) in treating severe acute cholangitis (AC) caused by common bile duct stones. This was a prospective, randomized controlled trial conducted between May 2021 and May 2024. A total of 126 patients diagnosed with severe acute cholangitis due to common bile duct stones, classified according to the Tokyo Guidelines 2018 (TG18), were selected. They were randomly divided into an ERCP group (n = 63) and a PTBD group (n = 63). Randomization was performed using a computer-generated sequence and allocation was concealed using sealed opaque envelopes. Operators could not be blinded, but outcome assessors and data analysts were blinded to group allocation. We compared therapeutic effects, procedural and recovery parameters, and incidence of complications. Levels of inflammatory factors and pain intensity were statistically analyzed. The primary end point was the length of hospital stay. Secondary end points included time to definitive stone clearance, time to first ambulation, procedure time, time to return of bowel function, changes in inflammatory markers, pain scores, therapeutic efficacy, patient-reported outcomes, and complication rates. There were no statistically significant differences in procedure time, estimated intraoperative blood loss, and time to return of bowel function between the two groups (P > 0.05). However, the ERCP group had significantly shorter times for first ambulation and hospital stay compared to the PTBD group (P < 0.001 for both). Definitive stone clearance during the initial procedure was achieved in 92.1% (58/63) of ERCP patients versus 0% in the PTBD group, resulting in a significantly shorter time to complete stone clearance in the ERCP group (2.1 ± 1.5 vs. 9.8 ± 3.4 days, P < 0.001). Initial therapeutic efficacy and technical success rates were high and similar between groups (98.4% vs. 96.8%). Both interventions significantly reduced inflammatory markers and pain scores, with no inter-group differences. However, patients in the PTBD group reported significantly higher drain-related discomfort at 72 h (P < 0.001). The total complication rates were similar (7.94% vs. 9.52%, P > 0.05). For severe acute cholangitis caused by common bile duct stones, ERCP provides a more efficient single-stage treatment, leading to faster definitive stone clearance, shorter recovery times, and better patient-reported comfort compared to the multi-stage approach required with initial PTBD, without an increase in complications.
本研究的目的是探讨内镜逆行胰胆管造影术（ERCP）与经皮经肝胆道引流术（PTBD）相比，在治疗胆总管结石引起的严重急性胆管炎（AC）方面的有效性和安全性。这是一项于2021年5月至2024年5月进行的前瞻性随机对照试验。总共选取了126例根据《2018年东京指南》（TG18）分类的因胆总管结石诊断为严重急性胆管炎的患者。他们被随机分为ERCP组（n = 63）和PTBD组（n = 63）。随机化使用计算机生成的序列进行，分配采用密封不透明信封进行隐藏。操作人员无法设盲，但结局评估者和数据分析人员对分组情况不知情。我们比较了治疗效果、操作和恢复参数以及并发症发生率。对炎症因子水平和疼痛强度进行了统计学分析。主要终点是住院时间。次要终点包括结石彻底清除时间、首次下床活动时间、操作时间、肠功能恢复时间、炎症标志物变化、疼痛评分、治疗效果、患者报告的结局以及并发症发生率。两组在操作时间、估计术中失血量和肠功能恢复时间方面无统计学显著差异（P > 0.05）。然而，与PTBD组相比，ERCP组的首次下床活动时间和住院时间明显更短（两者P均< 0.001）。ERCP组92.1%（58/63）的患者在初次操作时实现了结石彻底清除，而PTBD组为0%，这使得ERCP组完成结石清除的时间明显更短（2.1±1.5天对9.8±3.4天，P < 0.001）。初始治疗效果和技术成功率较高且两组相似（98.4%对96.8%）。两种干预措施均显著降低了炎症标志物和疼痛评分，组间无差异。然而，PTBD组患者在72小时时报告的引流相关不适明显更高（P < 0.001）。总并发症发生率相似（7.94%对9.52%，P > 0.05）。对于胆总管结石引起的严重急性胆管炎，与初始PTBD所需的多阶段方法相比，ERCP提供了一种更有效的单阶段治疗，导致结石彻底清除更快、恢复时间更短且患者报告的舒适度更高，同时并发症没有增加。
