Role of Endoscopic Ultrasound Guided Fine Needle Aspiration of Portal Vein Thrombus in the Diagnosis and Staging of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
研究概览
简要总结
Since not every portal vein thrombus (PVT) in a patient with hepatocellular carcinoma (HCC) is a tumor thrombus, since the nature of the thrombus will ultimately determine the course of treatment, and since PVT may be even the initial sign of an undetected HCC, every effort should be made to distinguish between a tumor and a non-tumor PVT. In addition, malignant PVT does not always demonstrate neovascularity and/or enhancement, which makes fine needle aspiration (FNA) necessary in order to characterize the nature of the PVT.
Sampling of portal vein thrombus with trans-abdominal ultrasound guidance may lead to erroneous results because of inadvertent inclusion of normal hepatocytes or associated liver masses. Further, potential adverse events of trans-abdominal portal vein sampling include serious biliary and/or vascular injury.
In contrast to the percutaneous approach, Endoscopic ultrasound (EUS) provides a unique view and access to the main portal vein. From the duodenal bulb and second part of the duodenum, the portal vein can be visualized from the confluence of the splenic and superior mesenteric veins into the porta hepatis. Periportal collateral vessels or cavernous transformation of the portal vein, which commonly are associated with portal vein thrombosis, are also easily and reliably detected by EUS instruments with color Doppler US capability.
With a linear-array echo-endoscope, the portal vein can be punctured easily with a fine needle under direct visualization, while avoiding the adjacent hepatic artery, bile duct, and collateral vessels (if present). Because the approach is not trans-hepatic, it eliminates any need to avoid the primary tumor and any possibility of contaminating the specimen with hepatocytes, as can occur if the needle tracks through the liver parenchyma. Thus, the rate of false-positive diagnoses is likely to be lower with the EUS compared with the percutaneous approach
详细描述
This is a pilot study that include 30 patients with liver cirrhosis and portal vein thrombus which don't fulfill the criteria of malignancy by imaging technique. The patients involved in the study were and will be admitted to Specialized Medical Hospital, Mansoura University Hospitals.
Study end-points:
• 24 months from the start of the research (cases will be collected over 18 months).
Methods:
Patients will be included in this study will be subjected to the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with liver cirrhosis and PVT which don't fulfill criteria of malignancy by triphasic CT abdomen defined as, (neovascularity of thrombus, arterial enhancement with rapid washout, direct invasion by adjacent hepatic mass and diameter of thrombus more than 23 mm), either :
- •With or without hepatic mass
- •Undergone local treatment or surgical treatment following a diagnosis of HCC and develop PVT during their follow up.
排除标准
- •Uncooperative or excessively apprehensive patient
- •Anticoagulation treatment or non-substituted coagulopathy (International Normalized Ratio ≥ 1.5, Platelet count ≤ 50.000 cells/mm3, heparin administration at therapeutic doses).
- •Inhibition of platelet aggregation by clopidogrel and other thienopyridines.
- •Contraindications of sedation (Uncontrolled Diabetes Mellitus, Uncontrolled Thyroid Disorders, Pregnancy, Respiratory Embarrassment, Reactional Drugs like Antidepressants and Anti-anxiety Agents).
- •Patients fulfilling criteria of malignancy by triphasic CT on abdomen.
- •Extra hepatic metastasis of HCC.
- •Child-Pugh classification stage C.
研究组 & 干预措施
EUS - FNA for benign PVT by imaging
Intervention: Procedure/Surgery: EUS guided fine needle aspiration of portal vein thrombus
干预措施: EUS guided fine needle aspiration of portal vein thrombus (Procedure)
结局指标
主要结局
Percentage of patients with portal vein thrombosis who underwent EUS guided FNA and had complications as a result of the invasive maneuver
时间窗: 2 days
assessment of safety of the procedure ( The patients admitted and the new ones will be admitted to specialized medical hospital for 24 h after the procedure to exclude the possibility of bleeding at puncture site, risk of biliary peritonitis, and extravasation from the site of the thrombus.
Percentage of patients with bland portal vein thrombosis diagnosed by triphasic abdominal CT who are proven to have malignant cells by histopathology obtained via EUS-guided FNA
时间窗: 3 days up to 2 weeks
Histopathology of biopsies taken from bland portal vein thrombus which diagnosed by triphasic CT abdomen to evaluate the possibility of malignant PVT that was not discovered by imaging technique (Abdominal ultrasound and triphasic abdominal CT )
次要结局
未报告次要终点