One-step versus two-step distal self-expandable metal stent placement: A multicenter prospective randomized trial
One-step versus two-step distal self-expandable metal stent placement: A multicenter prospective randomized trial
复制标题
一步与两步远端自扩张金属支架置入：一项多中心前瞻性随机试验
DOI：
10.1111/jgh.15393
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发表时间：
2020
期刊：
影响因子：
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通讯作者：
Kataoka H.
中科院分区：
文献类型：
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作者：
Shimizu S;Naitoh I;Okumura F;Hirano A;Miyabe K;Nishi Y;Takada H;Haneda K;Anbe K;Yoshida M;Kondo H;Sano H;Hayashi K;Kataoka H.
背景与目的经乳头覆膜自膨式金属支架(SEMS)置入治疗远端恶性胆道梗阻(MBO)有两种方法：一步引流(二步法)和无引流(一步法)。方法90例不能切除的胰腺癌并远端恶性胆道梗阻患者随机分为一步引流组(n=45)和二步引流组(n=45)。主要结果是再发胆道梗阻的时间(TRBO)。次要结果是早期和晚期不良事件的发生率、生存时间、降低胆红素水平所需的时间和成本效益。结果一步和两步组的TRBO中位数没有显著差异(不可用314天，P=0.134)。两步法组移行的发生率明显高于二步法组(14.3%vs0%，P=0.026)。早期(7.3%vs14.3%，P=0.483)和晚期(12.2%和11.9%，P=0.104)两组之间的不良事件发生率无显著差异，但RBO、生存期(P=0.104)或达到可接受化疗的胆红素水平所需天数的中位数(P=0.881)除外。一步法支架置入术和再介入治疗的总费用(3347美元比5465美元，P<；0.001)明显低于一步法组。结论TRBO加二步法支架置入术的优越性不明显。从成本效益和侵袭性的角度来看，一步放置SEMS可能是一种很有前途的方法(Umin-CTR临床试验注册号：UMIN000016010)。
Background and AimTwo methods of transpapillary covered self‐expandable metal stent (SEMS) placement are used for distal malignant biliary obstruction (MBO): after initial drainage by plastic stent (two‐step method) and without previous drainage (one‐step method).MethodsIn total, 90 patients with unresectable pancreatic cancer and distal MBO were enrolled in this prospective multicenter randomized study and allocated to one‐step (n= 45) and two‐step (n= 45) groups. The main outcome was the time to recurrent biliary obstruction (TRBO). Secondary outcomes were the rates of early and late adverse events, survival time, the time required for bilirubin level reduction, and cost‐effectiveness.ResultsThe median TRBO did not differ significantly between the one‐step and two‐step groups (not availablevs314 days,P= 0.134). SEMS migration occurred significantly more frequently in the two‐step group (14.3%vs0%,P= 0.026). No significant difference was observed between groups in early (7.3%vs14.3%,P= 0.483) or late (12.2% and 11.9%,P= 1) adverse events other than RBO, survival time (P= 0.104), or the median number of days required to reach a bilirubin level considered to be acceptable for chemotherapy administration (<3 mg/dL;P= 0.881). The total costs of stent placement and reintervention were significantly lower in the one‐step SEMS group (3347vs5465 US dollars,P< 0.001).ConclusionsThe superiority of TRBO with two‐step SEMS placement was not demonstrated. One‐step SEMS placement might be a promising method from the viewpoints of cost‐effectiveness and less invasiveness (UMIN‐CTR clinical trial registration number: UMIN000016010).