Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver

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Brief Title

Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver

Official Title

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

Brief Summary

      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.
    

Detailed Description

      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).

      Recent studies have shown that CT scan is far from ideal for detection of primary as well as
      metastases to liver (5,6). A well designed study showed that CT scan missed 32 % of the
      primary tumors of the liver. A prospective study of 100 patients with colorectal cancer
      showed that CT scan missed liver metastases in 37% of cases (5). Another prospective
      controlled study of 135 subjects showed that CT scan failed to detect liver metastases in 49%
      of patients with various malignancies (6).

      1.2 EUS as a possible diagnostic tool for liver tumors EUS is a well-established tool for the
      diagnosis and/ or staging of the esophageal, gastric and pancreatic cancer. Recent studies
      have shown a potential role of EUS for the liver imaging (7, 8, and 9).

      1.3 Comparison of EUS and CT scan for detection of liver metastases

      Studies suggest that EUS may be an attractive alternative to CT scan for detection of the
      liver metastases, since it can detect lesions that are missed on the CT scan (9). EUS
      detected metastatic lesions overlooked by conventional, cross-sectional imaging studies in 5
      of 222 cases (2.3%) (9). Another study found occult liver metastases in 2.4% of 574 patients
      with suspected GI or pulmonary malignancies (4). Each patient found to have occult metastases
      at EUS had staging CT, which raises an issue as to the quality and/or interpretation of those
      studies.

      An additional advantage of EUS is that fine needle aspiration (FNA) can be performed
      simultaneously and therefore confirmation of malignancy can usually be accomplished in a
      single procedure whereas CT or US typically require 2 sessions to accomplish these tasks, one
      for detection and another for FNA.

      1.4 Limitation of EUS: Right lobe The limitation of the EUS is that it is not able to examine
      the right lobe of the liver completely.

      1.5 Rationale for the study. The diagnostic accuracy of EUS for detection of the liver tumors
      (primary and metastatic) remains unknown. There is sufficient evidence to suggest that EUS
      may be superior to the CT scan for the liver metastases. Studies that have evaluated the role
      of EUS are limited by small sample size or retrospective design. Therefore, a prospective
      study with adequate sample size is required to determine the diagnostic accuracy of endoscopy
      ultrasound.

      2.0 Objectives:

      2.1 Primary:

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

      2.2 Secondary: 2.2.1 Determine the diagnostic yield of fine needle aspiration using EUS
      (EUS-FNA) in patients with suspected liver metastasis on EUS examination.

      2.2.2 Compare the accuracy of the PET scan with EUS for the detection of the liver
      metastases.

      2.2.3 Determine the safety of EUS-FNA in subjects with liver lesions. 2.2.4 Impact of the EUS
      on the management of the hepatocellular carcinoma 2.2.5 To study characteristic
      echoendoscopic findings of the primary and secondary liver tumor.

      2.3 Hypothesis: 2.3.1 EUS is likely to detect primary tumor and liver metastasis in subjects
      with normal CT scan.

      3.0 Design: This is a prospective study where study group would comprise of consecutive
      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.

      Patients would be selected from gastroenterology clinic, primary care clinic, surgery clinic,
      sub-specialty clinics (Oncology, Pulmonary) and hepatitis C clinic. These clinics would be
      informed about the ongoing EUS study and the eligibility criteria's of the study. All
      patients will be seen in the gastroenterology clinic where a detail description of the
      EUS-FNA procedure would be provided to them. In addition, patients would be provided consent
      forms. (Please refer to section 5 for details of the consent process.)

      Study population:

      Enrollment of participants.

      Patients enrolled in the study would undergo -

        -  Detailed history and physical examination,

        -  CT-abdomen preferably with contrast, and

        -  Possible PET scan. PET scan will be performed on patients who do not have evident
           distant metastasis.

        -  Intervention allocation: all eligible patients would be encouraged to undergo EUS and
           EUS-FNA examination.

      Intervention:

      Description and schedule: All eligible patients would undergo EUS examination of the liver.
      Any subject with abnormality suspicious for malignancy in liver would undergo FNA.

      Follow-up visits description and schedule. After the procedure patient would be referred back
      to the clinic from which the patient was identified for further management. These patients
      are usually seen by oncologists, pulmonologists and cardio-thoracic surgeon depending on the
      stage and the medical condition of the patient.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Secondary:

Condition

Hepatocellular Carcinoma

Intervention

Endoscopy ultrasound


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure


Start Date

July 2004

Completion Date

January 2006


Eligibility Criteria

        Inclusion Criteria:

        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.

        Exclusion Criteria:

          -  Advanced heart or lung disease that precludes conscious sedation

          -  Liver failure
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Pankaj Singh, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00290316

Organization ID

0002



Study Sponsor

Central Texas Veterans Health Care System


Study Sponsor

Pankaj Singh, MD, Principal Investigator, Central Texas Veterans Health Care System


Verification Date

January 2006