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Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis

2021年4月7日 更新者:Frederic PRAT, MD, PhD

Comparison of Two Diagnostic Strategies in Indeterminate Biliary Stenosis: Exploration by Retrograde Cholangioscopy From the Outset or After Failure of Conventional Techniques

Biliary stenosis not associated with a mass is difficult to diagnose with certainty. The diagnosis is usually based on a first-line cytological study of biliary brushing, which allows a diagnosis in 30 to 50% of cases. In the event of negativity, it is then possible to perform a cholangioscopy in a second step, which allows better sensitivity by performing biopsies. Performing cholangioscopy from the start could potentially save time and avoid disturbances associated with intermediate biliary stenting.

The main objective is to compare two strategies for exploring indeterminate biliary stenosis (1st vs. 2nd line retrograde cholangioscopy) in terms of diagnostic performance. The secondary objectives are to compare the same two strategies in terms of effectiveness, side effects and cost-effectiveness.

The primary outcome measure is the diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).

研究概览

研究类型

介入性

注册 (预期的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Clichy、法国、92110
        • 招聘中
        • Hopital Beaujon
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Presence of intra- or extrahepatic biliary stenosis, involving the main bile ducts: common hepatic duct, right and left hepatic ducts
  • Presence of clinical jaundice and / or biological cholestasis (GGT> 3N)
  • Absence of visible mass near the biliary stenosis after initial morphological assessment by abdominal CT scan, MRI with biliary sequences.
  • Endoscopic ultrasound performed and not having allowed the acquisition of material of diagnostic interest by guided puncture of the lesion.
  • No history of ERCP in the 6 months preceding inclusion and no biliary prosthesis (plastic or metal) in place at the time of inclusion
  • Collegial validation of the need for a formal diagnosis of indeterminate biliary stenosis in order to guide therapeutic management
  • Patients aged 18 to 85
  • Patient who gave his consent to participate in the study
  • No contraindication to anesthesia (ASA 1, 2,3)
  • Patient affiliated to a social security scheme (beneficiary or beneficiary)
  • Absence of pregnancy and current contraception in women of childbearing age

Exclusion Criteria:

  • Presence of a manifest tissue mass in relation to the biliary stenosis on CT and / or MRI imaging.
  • Very strong presumption of the etiological diagnosis of biliary stenosis given the history (history, background): i.e. liver surgery, cholecystectomy, autoimmunity
  • History of ERCP and / or percutaneous biliary drainage in the 6 months preceding inclusion
  • Presence of a plastic or metal biliary prosthesis in place at the time of inclusion
  • History of cephalic duodeno-pancreatectomy or hepatico-jejunal anastomosis
  • Non-passable stenosis of the main bile duct
  • Severe coagulopathy, thrombocytopenia <75,000 G / L, treatment with clopidogrel cannot be interrupted even temporarily
  • Anesthetic contraindication (ASA 4)
  • Inability to obtain informed consent
  • person deprived of liberty

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:cytological brushing followed by cholangioscopy in case of failure
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
实验性的:cholangioscopy from the start
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnostic yield (performance) of the initial investigation of indeterminate biliary stenosis: cytological brushing followed by cholangioscopy in case of failure (control group) or cholangioscopy from the start (study group).
大体时间:48 months
Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.
48 months

次要结果测量

结果测量
大体时间
Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention
大体时间:48 months
48 months
Rate of adverse events related to diagnostic procedures in each of the 2 groups
大体时间:48 months
48 months
Comparison of the costs of the 2 diagnostic strategies
大体时间:48 months
48 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年12月26日

初级完成 (实际的)

2018年12月26日

研究完成 (预期的)

2022年12月26日

研究注册日期

首次提交

2021年4月7日

首先提交符合 QC 标准的

2021年4月7日

首次发布 (实际的)

2021年4月12日

研究记录更新

最后更新发布 (实际的)

2021年4月12日

上次提交的符合 QC 标准的更新

2021年4月7日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • SFED 131

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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