不可切除恶性胆道梗阻的放疗支架与传统金属支架的比较：一项多中心试验。
Irradiation stents vs. conventional metal stents for unresectable malignant biliary obstruction: A multicenter trial.
机构信息
Department of Radiology, Zhongda Hospital, Southeast University, Nanjing 210009, China.
Department of Minimally Invasive Interventional Radiology, Yunnan Tumor Hospital, The Third Affiliated Hospital of Kunming Medical University, Kunming 650106, China.
出版信息
J Hepatol. 2018 May;68(5):970-977. doi: 10.1016/j.jhep.2017.12.028. Epub 2018 Jan 10.
BACKGROUND & AIMS: Placement of an irradiation stent has been demonstrated to offer longer patency and survival than an uncovered self-expandable metallic stent (SEMS) in patients with unresectable malignant biliary obstruction (MBO). We aim to further assess the efficacy of an irradiation stent compared to an uncovered SEMS in those patients.
METHODS
We performed a randomized, open-label trial of participants with unresectable MBO at 20 centers in China. A total of 328 participants were allocated in parallel to the irradiation stent group (ISG) or the uncovered SEMS group (USG). Endpoints included stent patency (primary), technical success, relief of jaundice, overall survival, and complications.
RESULTS
The first quartile stent patency time (when 25% of the patients experienced stent restenosis) was 212 days for the ISG and 104 days for the USG. Irradiation stents were significantly associated with a decrease in the rate of stent restenosis (9% vs. 15% at 90 days; 16% vs. 27% at 180 days; 21% vs. 33% at 360 days; p = 0.010). Patients in the ISG obtained longer survival time (median 202 days vs. 140 days; p = 0.020). No significant results were observed in technical success rate (93% vs. 95%; p = 0.499), relief of jaundice (85% vs. 80%; p = 0.308), and the incidence of grade 3 and 4 complications (8.5% vs. 7.9%; p = 0.841).
CONCLUSIONS
Insertion of irradiation stents instead of uncovered SEMS could improve patency and overall survival in patients with unresectable MBO.
LAY SUMMARY
For patients with unresectable malignant biliary obstruction (MBO), placement of a self-expandable metallic stent (SEMS) is a recommended palliative modality to relieve pruritus, cholangitis, pain, and jaundice. However, restenosis is a main pitfall after stent placement. Data from this first multicenter randomized controlled trial showed that insertion of an irradiation stent provided longer patency and better survival than a conventional metal stent. ClinicalTrials.gov ID: NCT02001779.
背景与目的
在无法切除的恶性胆道梗阻（MBO）患者中，与未覆盖的自膨式金属支架（SEMS）相比，放置放射性支架可提供更长的通畅率和生存率。我们旨在进一步评估与未覆盖的 SEMS 相比，放射性支架在这些患者中的疗效。
方法
我们在中国的 20 个中心进行了一项无法切除的 MBO 患者的随机、开放标签试验。共有 328 名患者被平行分配到放射性支架组（ISG）或未覆盖的 SEMS 组（USG）。终点包括支架通畅率（主要终点）、技术成功率、黄疸缓解、总生存率和并发症。
结果
ISG 的第一四分位支架通畅时间（当 25%的患者出现支架再狭窄时）为 212 天，USG 为 104 天。与 SEMS 相比，放射性支架显著降低了支架再狭窄率（9% vs. 15%，90 天；16% vs. 27%，180 天；21% vs. 33%，360 天；p=0.010）。ISG 组患者的生存时间更长（中位时间 202 天 vs. 140 天；p=0.020）。技术成功率（93% vs. 95%；p=0.499）、黄疸缓解率（85% vs. 80%；p=0.308）和 3 级和 4 级并发症发生率（8.5% vs. 7.9%；p=0.841）无显著差异。
结论
在无法切除的 MBO 患者中，插入放射性支架而非未覆盖的 SEMS 可改善通畅率和总体生存率。
患者教育
对于无法切除的恶性胆道梗阻（MBO）患者，自膨式金属支架（SEMS）放置是一种缓解瘙痒、胆管炎、疼痛和黄疸的推荐姑息性治疗方法。然而，支架放置后的再狭窄是一个主要的陷阱。这项首次多中心随机对照试验的数据表明，与传统金属支架相比，插入放射性支架可提供更长的通畅率和更好的生存率。临床试验注册：NCT02001779。
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