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临床试验/NCT01556555
NCT01556555已完成不适用

Prospective Evaluation of the Clinical Utility of Peroral Cholangiopancreatoscopy With the Spyglass System in Patients With Sclerosing Cholangitis

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1

研究概览

简要总结

This study aim to prospectively evaluate the clinical utility of Spyglass in sclerosing cholangitis patients undergoing endoscopic retrograde cholangiopancreaticography (ERCP). Fifty patients with a definite diagnosis of sclerosing cholangitis and a clinical indication for ERCP from September 2008 and onwards will be investigated with peroral cholangioscopy using Spyglass direct visualization system. Clinical data on all patients will be collected at time of the ERCP including information on the Primary sclerosing cholangitis (PSC) and inflammatory bowel disease (IBD), serum liver function tests and indication for ERCP.

A structured data collection form including information on Majoie Score, macroscopic features of the bile ducts at cholangioscopy, quality of the investigation, technical difficulties, and an overall judgment of whether any abnormalities observed were benign or malignant was completed by the endoscopist in conjunction with the procedure.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • sclerosing cholangitis with indication for ERCP
  • Over 18 year
  • informed consent

排除标准

  • Not able to sign informed consent

研究者

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annika Bergquist

Head of department of gastroenterology and hepatology, associate professor

Karolinska University Hospital

研究点 (1)

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