Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Ilsan Paik Hospital, Goyang, South Korea. Department of Internal Medicine, Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, South Korea. Department of Internal Medicine, Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Department of Internal Medicine, Dankook University College of Medicine, Dankook University Hospital, Cheonan, South Korea. Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. Department of Internal Medicine, Pusan National University School of Medicine, Pusan National University Hospital, Pusan, South Korea. These authors contributed equally to this article as first authors: Woo Hyun Paik, Tae Hoon Lee.
Am J Gastroenterol. 2018 Jul;113(7):987-997. doi: 10.1038/s41395-018-0122-8. Epub 2018 Jul 2.
The goal of the study was to determine whether endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is comparable to conventional transpapillary stenting with endoscopic retrograde cholangiopancreatography (ERCP) in palliation of malignant distal biliary obstruction. Although ERCP for the palliation of malignant biliary obstruction is the standard of care, post-procedure pancreatitis and stent dysfunctions are not uncommon. While EUS-BD has garnered interest as a viable alternative when ERCP is impossible, its role as a primary palliation of malignant distal biliary obstruction is yet to be proven.
We performed random allocation to EUS-BD or ERCP in 125 patients with unresectable malignant distal biliary obstruction at four tertiary academic referral centers in South Korea.
Technical success rates were 93.8% (60/64) for EUS-BD and 90.2% (55/61) for ERCP (difference 3.6%, 95% 1-sided confidence interval lower limit -4.4%, P = 0.003 for noninferiority margin of 10%). Clinical success rates were 90.0% (54/60) in EUS-BD and 94.5% (52/55) in ERCP (P = 0.49). Lower rates of overall adverse events (6.3% vs 19.7%, P = 0.03) including post-procedure pancreatitis (0 vs 14.8%), reintervention (15.6% vs 42.6%), and higher rate of stent patency (85.1% vs 48.9%) were observed with EUS-BD. EUS-BD was also associated with more preserved quality of life (QOL) than transpapillary stenting after 12 weeks of the procedure.
This study demonstrated comparable technical and clinical success rates between EUS-BD and ERCP in relief malignant distal biliary obstruction. Substantially longer duration of patency coupled with lower rates of adverse events and reintervention, and more preserved QOL were observed with EUS-BD (cris.nih.go.kr, Identifier: KCT0001396, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=9716<ype=&rtype= ).
本研究旨在确定内镜超声引导下胆道引流（EUS-BD）是否与传统的经内镜逆行胰胆管造影（ERCP）在缓解恶性远端胆道梗阻方面具有可比性。虽然 ERCP 是恶性胆道梗阻姑息治疗的标准方法，但术后胰腺炎和支架功能障碍并不少见。虽然 EUS-BD 作为 ERCP 不可能时的可行替代方案而备受关注，但它作为恶性远端胆道梗阻的主要姑息治疗手段尚未得到证实。
我们在韩国的四个三级学术转诊中心对 125 例不可切除的恶性远端胆道梗阻患者进行了 EUS-BD 或 ERCP 的随机分组。
EUS-BD 的技术成功率为 93.8%（60/64），ERCP 为 90.2%（55/61）（差异 3.6%，95%单侧置信区间下限-4.4%，P<0.003 非劣效性边界为 10%）。EUS-BD 的临床成功率为 90.0%（54/60），ERCP 为 94.5%（52/55）（P=0.49）。EUS-BD 的总体不良事件发生率较低（6.3% vs. 19.7%，P=0.03），包括术后胰腺炎（0 vs. 14.8%）、再干预（15.6% vs. 42.6%）和支架通畅率较高（85.1% vs. 48.9%）。EUS-BD 还与经乳头支架置入术后 12 周更高的生活质量（QOL）相关。
本研究表明，在缓解恶性远端胆道梗阻方面，EUS-BD 与 ERCP 的技术和临床成功率相当。EUS-BD 具有更长的通畅时间、更低的不良事件和再干预发生率，以及更好的 QOL。
