Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00290316
Study type Interventional
Source Central Texas Veterans Health Care System
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 2004
Completion date January 2006

See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Completed NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Completed NCT03268499 - TACE Emulsion Versus Suspension Phase 2
Recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT05263830 - Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
Recruiting NCT05095519 - Hepatocellular Carcinoma Imaging Using PSMA PET/CT Phase 2
Recruiting NCT05497531 - Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers N/A
Completed NCT05068193 - A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers Phase 1
Active, not recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Terminated NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Completed NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Withdrawn NCT05418387 - A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona N/A
Active, not recruiting NCT04039607 - A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma Phase 3
Terminated NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT06239155 - A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Completed NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2