Role of EUS in Detection of Liver Metastasis

May 16, 2021 updated by: Mahmoud Wahba

Role of EUS in Detection of Liver Metastasis Not Seen by CT or MRI During Staging of Pancreatic, Gastrointestinal, and Thoracic Malignancies.

Liver metastasis may not be detected by CT and MRI due to their small size while they can be detected by EUS. Also, EUS-FNA has a great impact in improving the diagnostic accuracy of EUS. Objectives: To assess the feasibility of EUS in the detection of occult small hepatic focal lesions at the time of primary tumor staging, not seen by CT or MRI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endoscopic ultrasound (EUS) was used firstly in 1980s as a diagnostic imaging technique for pancreatic lesions. It has the ability to detect the histological layers of the gastrointestinal (GI) tract wall as well as the periluminal structures.

EUS has been used to perform FNA from lesions that are difficult to access by conventional methods. EUS has the advantage of using both ultrasound and endoscopy to give the exact diagnostic features of the GI tract. The use of EUS was not limited to visualization only, but also in obtaining tissue biopsy for diagnostic purpose through EUS guided fine needle aspiration (FNA), and it has played a major role in revolutionizing the diagnosis of focal hepatic lesions as it is a minimally invasive procedure.

Abdominal imaging [CT, magnetic resonance imaging (MRI), and transabdominal ultrasonography (USG)] are the diagnostic tests of choice to detect hepatic lesions suspicious of metastasis.Unfortunately, these modalities are limited in their ability to detect hepatic lesions less than 1 cm.

In addition, although rare, percutaneous FNA for suspected metastatic lesions carries the risk of implantation metastasis. Although unable to completely visualize the entirety of the liver, EUS can detect small hepatic lesions that may be otherwise missed by conventional imaging. EUS can delineate detailed anatomy of the liver from the trans-gastric and trans-duodenal routes with the exception of the right posterior segments.

The prospect to obtain precise, ultrasound-guided biopsies of possible metastatic liver lesions can drastically alter the therapeutic conduct.

This, combined with limited adverse events, makes EUS an excellent modality to allow staging in malignant conditions. Due to the vicinity of the transducer to the liver, EUS provides detailed images of the liver segments and its vascular structures.

Based on the premise that EUS is more sensitive for the detection of small hepatic lesions then CT/MRI, Singh et al. proved that EUS was superior to CT scan (98% vs 92%, respectively) in diagnostic accuracy in its ability to detect the number of metastatic lesions in the liver and correctly diagnose the nature of the lesions .(Singh P etal.,2009) Endoscopic ultrasonography (EUS) has become an indispensable method for diagnosis and therapeutic procedures in gastroenterology and as experience with this technique is growing, new indications for EUS continue to emerge.

(Saraireh HA .,2017) Furthermore, the use of on-site cytopathology interpretation has further improved the diagnostic yield of EUS-FNA by helping to ensure that the samples obtained are representative of the target organ and adequate for diagnostic purposes.

Objectives: To assess the feasibility of EUS in detection of occult small hepatic focal lesions at the time of primary tumor staging, not seen by CT or MRI

All the patients will be subjected to:

  1. Thorough history talking including;

    • Age
    • Sex
    • Comorbidity
  2. Clinical general and local abdominal examination
  3. Abdominal US & CT abdomen

  4. laboratory investigations:

    1. complete blood count (CBC)
    2. Prothombin time ,INR
    3. Ceatinine , Urea
    4. Albumin
    5. ALT , AST
  5. Virological test for HIV, HCV and HBV
  6. CA-19-9 and alfa fetoproteins.
  7. EUS will be done to all patients. During EUS examination the liver will be examined thoroughly to detect hepatic focal lesions with possible EUS-FNA of any detected lesions.

All EUS examination with be done by EUS linear array Echoendoscope, Pentax EG-3870UTK attached to Hitachi Avius US machine under Propofol deep sedation.

The collected data will be organized and statistically analyzed.

Data collection tool:

Data including study design, participant demographics, stage and type of pancreatic and GI malignancy will be extracted and recorded on electronic data collection sheet. Data will be pooled for various arms in trials: Individual data for each outcome were entered into the Comprehensive analysis. Pooled effects with 95%CI will be reported. Data will be analyzed separately for each arm.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12613
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

400 pt , both male and female above 12 years All patients diagnosed with either pancreatic or gastrointestinal tumors and have undergone a CT scan of the abdomen with contrast or MRI before being referred for EUS for staging

Description

Inclusion Criteria:

  • All patients diagnosed with either pancreatic or gastrointestinal tumors and have undergone a CT scan of the abdomen with contrast or MRI before being referred for EUS for staging

Exclusion Criteria:

  • Patients are younger than 12 years. Patients who previously known to have HCC. Patient unfit for deep sedation by Propofol injection. Patients with bleeding disorders contraindicating EUS-FNA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of patients with occult hepatic metastasis missed by CT or MRI during staging of pancreatic and GI malignancy.
Time Frame: 6 months
pre-operative assessment of pancreatic neoplasms includes EUS examination to assess operability depending on the size, relation to blood vessels and metastasis. sometimes we found liver metastases missed during imaging evaluation by MRI and CT that could change the whole plan, so we aimed to study how frequent occult liver metastasis with be discovered during EUS staging of pancreatic cancer
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahmoud Wahba

Investigators

  • Principal Investigator: hussein Okasha, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2020

Primary Completion (ACTUAL)

April 21, 2021

Study Completion (ACTUAL)

April 21, 2021

Study Registration Dates

First Submitted

August 9, 2020

First Submitted That Met QC Criteria

August 9, 2020

First Posted (ACTUAL)

August 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 16, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ethical comittee N91/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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