NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.
Leeds Teaching Hospitals NHS Trust - Gastroenterology, Leeds, United Kingdom.
Gastrointest Endosc. 2021 Aug;94(2):321-328. doi: 10.1016/j.gie.2021.01.029. Epub 2021 Feb 3.
Biliary drainage with ERCP is successful in only 80% to 90% of cases of extrahepatic cholangiocarcinoma and pancreatic cancer. We present the results of a multicenter prospective study assessing the safety, feasibility, and quality of life of patients after EUS-guided biliary drainage (EUS-BD) with lumen-apposing metal stents after failed ERCP.
All consecutive adults with a dilated common bile duct (CBD) ≥14 mm secondary to inoperable malignant distal CBD stricture and failed ERCP biliary drainage were screened and recruited from 3 tertiary UK centers. Technical success of EUS-BD using lumen-apposing metal stents was the primary endpoint. Improvement in serum bilirubin level, 30-day mortality, procedure-related adverse events, and quality of life were secondary endpoints. Improvement in quality of life was measured using a validated questionnaire (EORTC QLQ-BIL21).
Twenty patients were included in the analysis. EUS-BD was technically successful in all patients and the clinical success rate was 95% (19 of 20) at day 7 (>50% reduction in bilirubin level) and 92.3% (12 of 13) at day 30 (bilirubin <50 μmol/L). There were significant improvements in overall quality of life score (49 vs 42, P = .03) at day 30. All-cause 30-day mortality was 20% and the moderate adverse event rate was 10% (1 cholangitis and 1 stent migration).
EUS-BD has acceptable technical success and safety as a second-line palliative treatment for inoperable malignant distal CBD strictures. Randomized controlled studies comparing EUS-BD with percutaneous transhepatic biliary drainage are needed to determine their effectiveness in clinical practice. (ISCRTN registration number: ISRCTN13196704.).
经内镜逆行胰胆管造影（ERCP）的胆管引流仅在 80%至 90%的肝外胆管癌和胰腺癌病例中获得成功。我们介绍了一项多中心前瞻性研究的结果，该研究评估了在 ERCP 失败后，使用内镜超声引导下胆管引流（EUS-BD）联合 lumen-apposing 金属支架治疗不可切除的远端 CBD 恶性狭窄导致的扩张性胆总管（CBD）≥14mm 的患者的安全性、可行性和生活质量。
所有连续的因不可切除的远端 CBD 恶性狭窄导致的扩张性 CBD≥14mm 且 ERCP 胆道引流失败的成年患者均接受筛查，并从英国 3 个三级中心招募。EUS-BD 使用 lumen-apposing 金属支架的技术成功率是主要终点。血清胆红素水平的改善、30 天死亡率、与操作相关的不良事件和生活质量是次要终点。使用经过验证的问卷（EORTC QLQ-BIL21）来测量生活质量的改善。
共有 20 名患者纳入分析。所有患者均成功完成 EUS-BD，技术成功率为 100%（20 例患者在第 7 天时的临床成功率为 95%（胆红素水平降低>50%），在第 30 天时为 92.3%（胆红素<50μmol/L））。第 30 天的总体生活质量评分有显著改善（49 分比 42 分，P=.03）。30 天全因死亡率为 20%，中度不良事件发生率为 10%（1 例胆管炎和 1 例支架迁移）。
EUS-BD 作为不可切除的远端 CBD 恶性狭窄的二线姑息治疗方法，具有可接受的技术成功率和安全性。需要进行随机对照研究比较 EUS-BD 与经皮经肝胆道引流术的效果，以确定其在临床实践中的有效性。（ISCRTN 注册号：ISRCTN85250344。）
