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临床试验/NCT01145248
NCT01145248已完成不适用

A Combination of Endoscopic Transpapillary Brush Cytology and a Novel Method of Forceps Biopsy to Diagnose Proximal Biliary Malignancies

University of Ulm2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
2
主要终点
Biopsy versus brush cytology for diagnosing CCC

研究概览

简要总结

Cholangiocarcinomas (CCCs) are malignant tumors arising from the biliary epithelium. CCCs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. Since surgery for CCC is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. However, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. This is reflected by a nearly 100% specificity but low sensitivity rates.

The aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (DBE) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • biliary stenosis with suspected malignancy

排除标准

  • no definite diagnosis available

结局指标

主要结局

Biopsy versus brush cytology for diagnosing CCC

时间窗: 6 months

For this study we recruit patients with proximal biliary stenoses, which are suspect for malignancy. An endoscopic retrograde cholangiography (ERC) will be performed on all patients . During ERC all subjects are undergoing both biopsy (using a double-balloon enteroscopy \[DBE\] forceps under a guidance of a pusher and guiding catheter with guidewire) and transpapillary brush cytology. The definite clinical diagnosis will be compared to cytological/histological results obtained by biopsy/cytology and accuracy will be evaluated.

次要结局

未报告次要终点

研究者

发起方
University of Ulm
申办方类型
Other

研究点 (2)

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