Cholangioscopy or Conventional Techniques for Indeterminate Biliary Stenosis
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
地位
条件
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Frederic Prat, MD, PhD
- 电话号码:+33 (0)140875663
- 邮箱:frederic.prat@aphp.fr
研究联系人备份
- 姓名:Diane Lorenzo, MD
- 邮箱:diane.lorenzo@aphp.fr
学习地点
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Clichy、法国、92110
- 招聘中
- Hopital Beaujon
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接触:
- frederic prat, MD, PhD
- 电话号码:+33 (0)140875663
- 邮箱:maximilien.barret@aphp.fr
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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
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 |
|---|---|
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有源比较器:cytological brushing followed by cholangioscopy in case of failure
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程序:endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
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实验性的:cholangioscopy from the start
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程序:endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP
endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
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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 |
|---|---|---|
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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
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Diagnostic performance is expressed primarily by sensitivity for the diagnosis of malignancy.
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48 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Specific rate of diagnosis with cholangioscopy by spyglass used in 1st or 2nd intention
大体时间:48 months
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48 months
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Rate of adverse events related to diagnostic procedures in each of the 2 groups
大体时间:48 months
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48 months
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Comparison of the costs of the 2 diagnostic strategies
大体时间:48 months
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48 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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