Background Drainage exceeding 50% of total liver volume is a beneficial prognostic factor in patients with unresectable malignant hilar biliary obstruction (UMHBO). However, it is unclear what threshold percentage of total liver volume drained ('liver drainage rate') significantly improves survival in patients with UMHBO who received systemic chemotherapy. Objectives We aimed to assess the optimal liver drainage rate that improves survival in patients with UMHBO receiving chemotherapy using a three-dimensional (3D)-image volume analyzer. Design This study was a single-center retrospective cohort study. Methods Data from 90 patients with UMHBO who received chemotherapy after endoscopic biliary drainage using metal stents at Okayama University Hospital from January 2003 to December 2020 were reviewed. The liver drainage rate was calculated by dividing the drained liver volume by the total liver volume using a 3D-image volume analyzer. The primary endpoint was overall survival by liver drainage rate. The secondary endpoints were time to recurrent biliary obstruction (TRBO) and prognostic factors. Results The median total liver volume was 1172 (range: 673-2032) mL, and the median liver drainage rate was 83% (range: 50-100). Overall survival was 376 (95% CI: 271-450) days, and patients with >80% drainage (n = 67) had significantly longer survival than those with <80% drainage (n = 23) (450 days versus 224 days, p = 0.0033, log-rank test). TRBO was 201 (95% CI: 155-327) days and did not differ significantly by liver drainage rate. Multivariate Cox proportional hazards regression analysis revealed >80% liver drainage [hazard ratio (HR): 0.35, 95% CI: 0.20-0.62, p = 0.0003] and hilar cholangiocarcinoma (HR: 0.30, 95% CI: 0.17-0.50, p < 0.0001) as significant prognostic factors. Conclusion In patients with UMHBO scheduled for chemotherapy, >80% drainage is associated with improved survival. Further prospective multicenter studies are needed to verify the results of this study. Trail registration Okayama University Hospital, IRB number: 2108-011.

中文翻译：

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使用 3D 图像体积分析仪确定不可切除的恶性肝门胆道梗阻患者生存的最佳肝脏引流率。

背景 对于不可切除的恶性肝门胆道梗阻 (UMHBO) 患者，引流超过肝脏总体积的 50% 是一个有益的预后因素。然而，尚不清楚总肝脏引流体积的阈值百分比（“肝脏引流率”）可显着改善接受全身化疗的 UMHBO 患者的生存率。目的 我们旨在使用三维 (3D) 图像体积分析仪评估可提高接受化疗的 UMHBO 患者生存率的最佳肝脏引流率。设计本研究是一项单中心回顾性队列研究。方法 回顾性分析 2003 年 1 月至 2020 年 12 月在冈山大学医院接受金属支架内镜胆道引流术后化疗的 90 例 UMHBO 患者的资料。使用 3D 图像体积分析仪，通过将引流的肝脏体积除以总肝脏体积来计算肝脏引流率。主要终点是按肝引流率计算的总生存率。次要终点是复发性胆道梗阻（TRBO）的时间和预后因素。结果 中位肝脏总体积为1172 mL（范围：673~2032）mL，中位肝引流率为83%（范围：50~100）。总生存期为 376 天（95% CI：271-450）天，引流率 > 80% 的患者 (n = 67) 的生存期明显长于引流率 < 80% 的患者 (n = 23)（450 天与 224 天， p = 0.0033，对数秩检验）。TRBO 为 201 (95% CI: 155-327) 天，并且肝脏引流率没有显着差异。多变量 Cox 比例风险回归分析显示 >80% 肝引流 [风险比 (HR): 0.35, 95% CI: 0.20-0.62, p = 0.0003] 和肝门部胆管癌 (HR: 0.30, 95% CI: 0.17-0.50, p < 0.0001）作为重要的预后因素。结论 在计划接受化疗的 UMHBO 患者中，>80% 的引流与生存率的改善相关。需要进一步的前瞻性多中心研究来验证本研究的结果。跟踪注册冈山大学医院，IRB 编号：2108-011。