ERCP for the initial management of malignant biliary obstruction – real world data on 596 procedures

To evaluate outcomes of ERCP as first-line management in patients with malignant biliary obstruction (MBO) of all causes and stages, reflecting a real-life setting. Retrospective observational study of patients with ERCP as the first-line management of MBO at Oslo University Hospital between 2015 and 2021. Primary outcome measure was <i>a</i> ≥ 50% decrease from the pre-procedural bilirubin within 30 days after ERCP. Secondary outcome measures were technical success of ERCP, complications and overall mortality. A total of 596 patients were included, median age 70 years. ASA score was ≥ III in 67% of patients. The most common cancers causing MBO were pancreatic cancer (52%), metastatic lesions (20%) and cholangiocarcinoma (16%). The primary outcome measure was achieved in 62% of patients. With endoscopic access, overall technical success was 80% with 85% for the distal extrahepatic group, 71% for the perihilar, 40% for the intrahepatic and 53% for multiple level MBOs. Reinterventions were performed in 27% of the patients. Complications occurred in 15% of the patients, including post-ERCP pancreatitis in 9%. Most complications were of minor/moderate severity (81%). Overall mortality was 33% within the first 90 days. Patients deceased by the end of the study period (83%) had median survival of 146 days (range 1–2,582 days). ERCP has a high rate of clinical effect and technical success in the management of both distal extrahepatic and perihilar MBO. Our data indicate that ERCP is a valid option in the first-line management of MBO.本研究旨在评估内镜逆行胰胆管造影（Endoscopic Retrograde Cholangiopancreatography, ERCP）作为各类病因与分期的恶性胆道梗阻（Malignant Biliary Obstruction, MBO）患者一线治疗方案的临床结局，以还原真实临床实践场景。本研究为2015年至2021年在奥斯陆大学医院开展的回顾性观察性研究，纳入以ERCP作为恶性胆道梗阻一线治疗的患者队列。主要结局指标为ERCP术后30天内，患者血清胆红素水平较术前下降≥50%。次要结局指标包括ERCP技术成功率、并发症发生率及总死亡率。本研究共纳入596例患者，中位年龄70岁。67%的患者美国麻醉医师协会（American Society of Anesthesiologists, ASA）分级≥Ⅲ级。引发恶性胆道梗阻的最常见恶性肿瘤为胰腺癌（52%）、转移性病灶（20%）与胆管癌（16%）。62%的患者达成主要结局指标。经内镜路径实施操作时，整体技术成功率为80%：其中远端肝外梗阻组为85%，肝门部梗阻组为71%，肝内梗阻组为40%，多部位梗阻组为53%。27%的患者接受了再次干预。15%的患者出现并发症，其中9%为ERCP术后胰腺炎。多数并发症为轻中度严重程度（占总并发症的81%）。术后90天内总死亡率为33%。83%的患者在研究周期结束时已死亡，该类患者的中位生存期为146天（范围1~2582天）。ERCP在远端肝外及肝门部恶性胆道梗阻的治疗中，临床有效率与技术成功率均较高。本研究数据表明，ERCP可作为恶性胆道梗阻一线治疗的合理选择。