NCT00290316

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
Last Updated

June 7, 2006

Status Verified

January 1, 2006

First QC Date

February 10, 2006

Last Update Submit

June 5, 2006

Conditions

Keywords

Hepatocellular carcinomaCholangiocarcinomaMetastasisLiver neoplasm

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

  • Secondary:

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

  • 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

  • +1 more secondary outcomes

Interventions

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Texas Veterans health Care System

Temple, Texas, 76504, United States

Location

Related Publications (2)

  • Singh P, Mukhopadhyay P, Bhatt B, Patel T, Kiss A, Gupta R, Bhat S, Erickson RA. Endoscopic ultrasound versus CT scan for detection of the metastases to the liver: results of a prospective comparative study. J Clin Gastroenterol. 2009 Apr;43(4):367-73. doi: 10.1097/MCG.0b013e318167b8cc.

  • Singh P, Erickson RA, Mukhopadhyay P, Gopal S, Kiss A, Khan A, Ulf Westblom T. EUS for detection of the hepatocellular carcinoma: results of a prospective study. Gastrointest Endosc. 2007 Aug;66(2):265-73. doi: 10.1016/j.gie.2006.10.053. Epub 2007 Jun 1.

MeSH Terms

Conditions

Carcinoma, HepatocellularCholangiocarcinomaNeoplasm MetastasisLiver Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pankaj Singh, MD

    Central Texas Veterans Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

July 1, 2004

Study Completion

January 1, 2006

Last Updated

June 7, 2006

Record last verified: 2006-01

Locations