Role of Digital Image Analysis in Diagnosing Nature of Indeterminate Biliary Duct Stricture
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
Ahmed Mohammed Abu Elfatth
Al-rahji University Hospital, Faculty of Medicine, Assiut, Egypt
Assiut University
