Hakuta Ryunosuke, Kogure Hirofumi, Nakai Yousuke, Kawakami Hiroshi, Maguchi Hiroyuki, Mukai Tsuyoshi, Iwashita Takuji, Saito Tomotaka, Togawa Osamu, Matsubara Saburo, Hayashi Tsuyoshi, Maetani Iruru, Ito Yukiko, Hasebe Osamu, Itoi Takao, Hanada Keiji, Isayama Hiroyuki
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan.
Department of Endoscopy and Endoscopic Surgery, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan.
J Clin Med. 2021 Jan 8;10(2):206. doi: 10.3390/jcm10020206.
(1) Background: Endoscopic management of hilar biliary obstruction is still challenging. Compared with unilateral drainage, bilateral drainage could preserve larger functional liver volume and potentially improve clinical outcomes. To evaluate the effectiveness of bilateral drainage, we conducted this multicenter randomized controlled study. (2) Methods: Patients with unresectable malignant hilar biliary obstruction were assigned to unilateral or bilateral group. At first, patients underwent endoscopic nasobiliary drainage (ENBD), and subsequently underwent self-expandable metallic stent (SEMS) deployment. Primary outcomes were the functional success rate of ENBD and time to recurrent biliary obstruction (TRBO) after SEMS deployment. (3) Results: During the study period, 38 and 39 patients were enrolled in the unilateral and bilateral groups. The functional success rate was similar in the uni- and bi-ENBD group (57% vs. 56%; = 0.99), but the rate of additional drainage was higher in uni-ENBD group. Although TRBO and overall survival time after SEMS deployment were not different between the groups ( = 0.11 and 0.78, respectively), the incidence of early adverse events tended to be higher in the bi-SEMS group (5.3% vs. 28%; = 0.11). (4) Conclusions: Our study failed to demonstrate the superiority of bilateral over unilateral biliary drainage in terms of functional success rate and TRBO.
(1) 背景：肝门部胆管梗阻的内镜治疗仍然具有挑战性。与单侧引流相比，双侧引流可保留更大的功能性肝体积，并有可能改善临床结局。为评估双侧引流的有效性，我们开展了这项多中心随机对照研究。(2) 方法：将无法切除的恶性肝门部胆管梗阻患者分为单侧组或双侧组。首先，患者接受内镜鼻胆管引流（ENBD），随后植入自膨式金属支架（SEMS）。主要结局指标为ENBD的功能成功率以及SEMS植入后胆管梗阻复发时间（TRBO）。(3) 结果：在研究期间，单侧组和双侧组分别纳入38例和39例患者。单侧ENBD组和双侧ENBD组的功能成功率相似（57% 对56%；P = 0.99），但单侧ENBD组的额外引流率更高。虽然两组在SEMS植入后的TRBO和总生存时间方面无差异（分别为P = 0.11和0.78），但双侧SEMS组早期不良事件的发生率更高（5.3% 对28%；P = 0.11）。(4) 结论：我们的研究未能证明在功能成功率和TRBO方面双侧胆管引流优于单侧胆管引流。
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