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临床试验/NCT00290316
NCT00290316Unknown2 期

Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver - A Prospective Study

Central Texas Veterans Health Care System2 个研究点 分布在 1 个国家开始时间: 2004年7月1日最近更新:
适应症

试验速览

阶段
2 期
发起方
试验地点
2
主要终点
To compare the accuracy of the EUS and CT scan for detection of the primary and metastatic carcinoma of the liver.

研究概览

简要总结

The diagnostic accuracy of EUS for detection of the liver tumors (primary and metastatic) remains unknown. To compare the accuracy of the EUS and CT scan for detection of the primary and metastatic carcinoma of the liver.

详细描述

The incidence of hepatocellular carcinoma is increasing in US. The reason for this increase has been attributed to the emergence of hepatitis C. Studies suggest that patients with hepatitis C are at higher risk of developing hepatocellular carcinoma (elevated alpha-fetoprotein) and, therefore should undergo periodic radiological investigation.

The liver is also a common site for metastases for various malignancies. The metastasis to liver profoundly affects the management and prognosis, since these patients have advanced cancer and therefore are not candidates for surgery.

1.1 Current standards of care

For primary liver tumors alpha-fetoprotein, abdominal ultrasound and CT scan of the abdomen are the suggested tests for the screening in patients that are at higher risk of developing this complication. Measurement of serum alpha-fetoprotein (AFP) may be helpful in the diagnosis and management of HCC. AFP is elevated above 20 ng/Ml in more than 70% of patients with HCC. However, AFP elevations from 10-500 ng/Ml and even occasionally to 1000 ng/ml may be seen in patients with a high degree of inflammatory activity such as with chronic viral hepatitis, who do not have HCC (3). The sensitivity, specificity, and positive predictive value of AFP in 3 well performed screening studies for HCC ranged from 39%-64%, 76%-91%, and 9%-32%, respectively (4). Imaging studies play a key role in the diagnosis of HCC since a significant number of cases are missed by AFP. CT scan and magnetic resonance imaging are commonly used tests.

On the basis of studies conducted over last two decades, National Comprehensive Cancer Network (2004) guidelines for the management of cancer recommended CT scan for the evaluation of the liver for metastases (Please refer to appendix III).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with newly diagnosed colon, pancreatic, esophageal, lung, gastric cancer and patient with hepatitis C or B with elevated levels of alpha-fetoprotein or radiological findings suggestive of mass in the liver.

排除标准

  • Advanced heart or lung disease that precludes conscious sedation
  • Liver failure

结局指标

主要结局

To compare the accuracy of the EUS and CT scan for detection of the primary and metastatic carcinoma of the liver.

次要结局

  • Determine the diagnostic yield of fine needle aspiration using EUS (EUS-FNA) in patients with suspected liver metastasis on EUS examination.
  • Secondary:
  • 2.2.5 To study characteristic echoendoscopic findings of the primary and secondary liver tumor.
  • Compare the accuracy of the PET scan with EUS for the detection of the liver metastases.
  • Determine the safety of EUS-FNA in subjects with liver lesions.
  • Impact of the EUS on the management of the hepatocellular carcinoma

研究者

发起方
Central Texas Veterans Health Care System
申办方类型
Other

研究点 (2)

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