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临床试验/ACTRN12620000217909
ACTRN12620000217909尚未招募未知

Randomized comparison of endoscopic bilateral stent-in-stent (SIS) versus stent-by-stent (SBS) placement for inoperable advanced malignant hilar biliary stricture: a multi-centre trial proposal.

Royal Adelaide Hospital0 个研究点目标入组 16 人开始时间: 2020年2月24日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
入组人数
16

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 85 Years(—)
性别
All

入选标准

  • All patients who have pathologically confirmed inoperable Malignant Hilar Biliary Strictures (MHSs) of Bismuth type III or IV with an estimated survival >3 months (Eastern Cooperative Oncology Group scale, <2) will be eligible for recruitment into the study. All causes of malignancy are included.
  • The criteria for inoperability were based on imaging studies such as Computed Tomography (CT) scan, Magnetic resonance cholangiopancreatography imaging (MRCP); cholangiography; positron emission tomography-CT; presence of comorbidities; and consensus of the surgeons.

排除标准

  • Uncontrolled coagulopathy, American Society of Anaesthesiologist Class V, inaccessible papilla because of an accompanying duodenal obstruction or altered anatomy, and the inability to provide informed consent. Patients with MHSs caused by multiple metastatic lesions or lobes diffusely occupied by a massive tumour were also excluded because drainage could not be performed effectively and such cases have an inherently poor survival rate.

研究者

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