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临床试验/NCT04112030
NCT04112030已完成不适用

Role of Digital Image Analysis in Diagnosing Nature of Indeterminate Biliary Duct Stricture

Assiut University0 个研究点目标入组 50 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Diagnostic performance of DIA compared to routine cytology in case of IBDS

研究概览

简要总结

The study aimed to assess role of DIA in diagnosing nature of indeterminate bile ducts stricture

详细描述

Biliary strictures (BSs) are common in clinical practice, but differentiating nature of the stricture either benign or malignant remains a challenge. Although there is a great advance in imaging and laboratory investigations, nature of BS is still unclear in some patients. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management.

BS is considered indeterminate biliary duct stricture (IBDS) if it has the following conditions; 1) no obvious mass on abdominal ultrasound (US), or magnetic resonance cholangiopancreatography (MRCP); 2) no distant metastasis on abdominal US, or MRI; and 3) no recent history of hepatobiliary surgery in the last 3 months.

IBDS has a particularly complex challenge, because patients and their physicians must weigh the malignant potential against benign etiologies in the face of morbidity of surgical intervention. About 15-24% of the patients had surgical intervention for suspected IBDS have a benign aetiology. Therefore, preoperative evaluation of such strictures is mandatory to put suitable plan with appropriate management.

Conventional cytological evaluation (CCE) has become the standard modality of practice for the investigation of such stricture. CCE had low diagnostic yield with an overall sensitivity of 41.6% and a negative predictive value of 58%. This low diagnostic yield is mainly attributed to desmoplastic reaction in BS.

Radiological elevation of BS with different modalities as MRCP enables us to detect the stricture and its extent and exclude other causes of obstruction. These modalities fail to determine nature of BS in many cases. In addition to, inability to take tissue sampling or perform therapeutic intervention.

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
否

入选标准

  • •Any patient presented with biliary stricture with no obvious cause in abdominal imaging

排除标准

  • •biliary obstruction due to other causes as stones, or tumor,
  • •biliary surgery within the last six months
  • •Coagulopathy
  • •lost follow up

结局指标

主要结局

Diagnostic performance of DIA compared to routine cytology in case of IBDS

时间窗: Baseline

all samples were subjected to DIA and routine cytology and the result was compared with final diagnosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Mohammed Abu Elfatth

Al-rahji University Hospital, Faculty of Medicine, Assiut, Egypt

Assiut University

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