Department of Medicine, KhonKaen University, KhonKaen, Thailand.
Gastrointest Endosc. 2012 Jul;76(1):93-9. doi: 10.1016/j.gie.2012.02.048. Epub 2012 May 15.
Endoscopic biliary stent drainage is effective in the palliative treatment of patients with hilar cholangiocarcinoma (HCA). However, no randomized controlled trial comparing the efficacy of the self-expandable metal stent (SEMS) and the plastic stent (PS) in patients with unresectable complex HCA is available.
To compare the successful drainage rates of endoscopic SEMSs and PSs.
A single-center, open-label randomized controlled trial.
University hospital in KhonKaen, Thailand.
One hundred eight patients with unresectable complex, Bismuth type II-IV HCA.
Endoscopic retrograde cholangiography with unilateral SEMS or PS insertion.
Successful drainage rate.
Diagnosis of HCA was made by clinical presentations, imaging studies, and clinical outcome during follow-up.
One hundred eight patients were randomly allocated to the SEMS and PS groups. Intention-to-treat analysis revealed that the successful drainage rate in the SEMS group was higher than in the PS group (70.4% vs 46.3%, P = .011). The median survival times were 126 and 49 days, respectively, in the SEMS and PS groups. The overall survival rates of the patients in both groups were statistically different by log-rank test (P = .002).
Endoscopic biliary drainage with the SEMS provides better adequacy of drainage and longer survival compared with the PS in patients with unresectable complex HCA.
内镜下胆道支架引流术在治疗肝门部胆管癌（HCA）患者的姑息治疗中是有效的。然而，目前尚无比较不可切除的复杂 HCA 患者使用自膨式金属支架（SEMS）和塑料支架（PS）的疗效的随机对照试验。
比较内镜下 SEMS 和 PS 的引流成功率。
单中心、开放标签的随机对照试验。
泰国孔敬大学医院。
108 例不可切除的复杂 Bismuth Ⅱ-Ⅳ型 HCA 患者。
经内镜逆行胆胰管造影术，单侧放置 SEMS 或 PS。
引流成功率。
HCA 的诊断是通过临床症状、影像学研究和随访期间的临床结果做出的。
108 例患者被随机分配到 SEMS 和 PS 组。意向治疗分析显示，SEMS 组的引流成功率高于 PS 组（70.4%比 46.3%，P =.011）。SEMS 组和 PS 组的中位生存时间分别为 126 天和 49 天。两组患者的总生存率经对数秩检验有统计学差异（P =.002）。
与 PS 相比，不可切除的复杂 HCA 患者采用 SEMS 进行内镜胆道引流可提供更好的引流效果和更长的生存时间。
