Comparison Between Triphasic CT Abdomen and EUS-FNB in Characterization of Pancreatic Lesion
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign from malignant pancreatic lesions.
研究概览
简要总结
evaluate the relationship between triphasic CT and EUS findings and the characterization of pancreatic lesions.
详细描述
Comparison Between Triphasic CT and EUS-FNB in characterization of Pancreatic Lesions
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •*Adult patients (age>18 years) presenting with focal pancreatic lesions detected on initial imaging.
- •Patients referred for further evaluation by triphasic CT and/or EUS-guided biopsy.
- •Patients able to provide informed consent
排除标准
- •Previous pancreatic surgery.
- •Known metastatic disease at presentation.
- •Contraindications to contrast-enhanced CT (e.g. severe renal impairment, contrast allergy)
- •Contraindications to EUS or biopsy (e.g., coagulopathy uncorrected, severe cardiopulmonary instability).
- •Pregnancy.
研究组 & 干预措施
Patients assessed by Triphasic CT scan
Triphasic CT scan:
Performed using a multidetector CT scanner and CT parameters assessed:
Size, shape, and margins of the lesion Enhancement pattern (hypo / iso / hyper-enhancing) Calcifications or cystic components
干预措施: Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings. (Diagnostic Test)
Patients assessed by Endoscopic Ultrasound (EUS)&Tissue Sampling
Performed using linear echoendoscope under conscious sedation or general anesthesia EUS-guided sampling Fine-needle aspiration (FNA) or fine-needle biopsy (FNB) using 19G/22G needles.
Multiple passes obtained for cytology and histopathology.
干预措施: Full clinical history (pain, jaundice, weight loss, pancreatitis history). Physical examination with focus on abdominal and systemic findings. (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign from malignant pancreatic lesions.
时间窗: one year
the diagnostic accuracy of triphasic CT compared to EUS-guided biopsy in differentiating benign and malignant pancreatic lesions, calculated in terms of sensitivity, specificity, PPV, NPV, and overall accuracy, using final histopathological diagnosis as the reference standard.
次要结局
未报告次要终点
研究者
Shaza Mamdouh sayed Abd el-galil
Doctor
Assiut University