Comparison of endoscopic bilateral metal stent drainage with plastic stents in the palliation of unresectable hilar biliary malignant strictures: Large multicenter study

Comparison of endoscopic bilateral metal stent drainage with plastic stents in the palliation of unresectable hilar biliary malignant strictures: Large multicenter study
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DOI:
10.1111/den.13680
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发表时间:
2020-06-07
影响因子:
5.3
通讯作者:
Hu, Bing
Hu, Bing
中科院分区:
医学2区
文献类型:
--
作者:
Xia, Ming-Xing;Pan, Yang-Lin;Hu, Bing

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背景:恶性肝门部胆道梗阻的内窥镜支架置入术对于最佳的支架置入策略尚无共识。在这项多中心研究中,我们比较了经乳头平行式双侧金属支架和双侧塑料支架,并评估了短期和长期结果。方法我们在四个三级中心招募了262名连续接受双侧金属或塑料支架治疗的患者(Bismuth分类II-IV型)。为了克服选择偏差,我们进行了1:1倾向得分匹配。结果在倾向性评分匹配后,每组包括96名患者,在任何基线特征上都没有显著差异。金属支架组中位生存期(7.2月[95%CI6.0~8.5])明显长于塑料支架组(4.1个月[95%CI2.9~5.3];P=0.015)。金属支架组的临床成功率显著高于塑料支架组(分别为99.0%和71.9%;P<0.001),术后胆管炎发生率较低(7.3%和26.0%;P<0.001),中位无症状支架通畅率较长(9.2月[95%可信区间7.6~10.6]vs 4.8个月[95%可信区间4.2~5.3];0.001),总干预措施较少(1.3%+/-0.6vs.2.0+/-1.4%;P<0.001)。多因素COX分析显示,金属支架置入术(HR 0.589,P=0.002)、肝门部胆管癌(HR 0.419,P=0.009)和辅助治疗(HR 0.596,P=0.006)是影响晚期肝门部胆道恶性肿瘤患者死亡的独立危险因素。结论双侧金属支架内窥镜治疗晚期肝门部胆道恶性肿瘤优于双侧塑料支架置入术,具有总生存期长、临床成功率高、支架通畅期长等优点。
Background Endoscopic stenting to manage malignant hilar biliary obstruction has no consensus regarding the optimal stenting strategy. In this multicenter study, we compared transpapillary parallel-style bilateral metal stenting with bilateral plastic stenting, and evaluated short- and long-term outcomes.Methods We recruited 262 consecutive patients (Bismuth classification types II-IV) who underwent either bilateral metal or plastic stenting as primary therapy at four tertiary centers. To overcome selection bias, we performed 1:1 propensity score matching. Our primary outcome was overall survival.Results After propensity score matching, each group comprised 96 patients, with no significant differences in any baseline characteristics. The median survival was significantly longer in the metal stenting group than in the plastic stenting group (7.2 months [95% CI 6.0-8.5] vs. 4.1 months [95% CI 2.9-5.3]; P = 0.015). The clinical success rates were significantly higher in the metal stenting group than in the plastic stenting group (99.0% vs. 71.9%, respectively; P < 0.001), and lower post-procedure cholangitis incidence (7.3% vs. 26.0%; P < 0.001), longer median symptom-free stent patency (9.2 months [95% CI 7.6-10.6] vs. 4.8 months [95% CI 4.2-5.3]; P < 0.001), and fewer total interventions (1.3 +/- 0.6 vs. 2.0 +/- 1.4; P < 0.001). In multivariate Cox analysis of the overall survival, metal stenting (HR 0.589, P = 0.002), hilar cholangiocarcinoma (HR 0.419, P = 0.009), and adjuvant treatment (HR 0.596, P = 0.006) were independent predictors of death.Conclusions Endoscopic therapy using bilateral metal stenting is superior to bilateral plastic stenting, with prolonged overall survival, higher clinical success, and longer stent patency in patients with advanced hilar biliary malignancies.