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Gastroesophageal VaricesNCT03910413

Dual Energy CT as a Noninvasive Method to Screen for Gastroesophageal Varices

A study testing Duel Energy CT in people with Gastroesophageal Varices, run by University of Alabama at Birmingham at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Cirrhosis leads to portal hypertension and development of gastroesophageal varices, which are the most common cause for bleeding in cirrhosis and a major cause of death. The American Association for the Study of Liver Disease (AASLD) recommends screening endoscopy every 2 years to evaluate for gastroesophageal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastroesophageal Varices
What is being tested?
Duel Energy CT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
5 Jun 2019to 6 Jul 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients with cirrhosis presenting to UAB Endoscopy for surveillance endoscopy to detect and grade gastroesophageal varices

Who cannot join

  • Inability to provide written informed consent
  • History of bleeding gastroesophageal varices, variceal intervention or portosystemic shunt
  • Prior liver transplant
  • History of malignancy
  • Severe chronic kidney disease with estimated glomerular filtration rate (GFR) < 30 mL/min/1.73 m2
  • Presence of acute kidney injury
Show all 11Show fewer
  • Prior iodinated contrast allergy
  • Patient weight >300 lbs
  • Multiphasic liver CT within 3 months of upper endoscopy
  • Pregnancy
  • Inclusion of all races and ethnic groups are eligible for this trial. There is no bias towards age or race in this trial. The trial is open the accrual of women and men.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UAB Hospital Outpatient Imaging, Leeds and Gardendale locations

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Cirrhosis leads to portal hypertension and development of gastroesophageal varices, which are the most common cause for bleeding in cirrhosis and a major cause of death. The American Association for the Study of Liver Disease (AASLD) recommends screening endoscopy every 2 years to evaluate for gastroesophageal varices, and annual surveillance for those with small varices on endoscopy. Unfortunately, endoscopy is costly, requires sedation, is poorly tolerated, is subject to high inter-observer variability, and is associated with risks that include bleeding, esophageal injury and aspiration. Noninvasive methods for evaluation of gastroesophageal varices are needed. CT is noninvasive, rapid, less expensive than endoscopy, requires no sedation, provides a quantitative measure of the size of the varices, and allows for assessment of para-esophageal varices, varices in other body locations, ascites, other signs of portal hypertension, patency of liver vasculature, and detection, diagnosis and staging of hepatocellular carcinoma. Single-Energy CT (SECT) has relatively high accuracy in prospective studies for detection of any and large varices but is associated with suboptimal contrast opacification of gastroesophageal varices. Dual-Energy CT with the GE scanners with GSI Xtream (DECT) improves the contrast-to-noise ratio by 60% compared to SECT and is currently standard of care at UAB for evaluation of cirrhosis. The primary objective of this study is to determine the accuracy of DECT for detecting any varices and high-risk varices. The study hypothesis is that the accuracy (AUROC) of DECT will be >0.90 and >0.95 for detecting any and high-risk varices in a prospective pilot study (N=50) that uses endoscopy as the reference standard. This will be a single-center pilot observational prospective IRB-approved study. A total of 50 adult patients presenting to UAB Endoscopy for surveillance endoscopy to detect and grade gastroesophageal varices will be enrolled.

Read the detailed description

Cirrhosis leads to portal hypertension and development of gastroesophageal varices, which are the most common cause for bleeding in cirrhosis and a major cause of death. Bleeding varices have a 6-week mortality of 15%-25%. About 50% of patients with cirrhosis have varices, and 30% have large varices (>5 mm) that are high risk for bleeding.

The American Association for the Study of Liver Disease (AASLD) recommends screening endoscopy every 2 years to evaluate for varices, and annual surveillance for those with small varices on endoscopy. Patients at a high risk of bleeding with large varices, small varices and red wale signs (an endoscopic finding), or small varices and decompensated cirrhosis proceed to treatment such as prophylactic band ligation and beta blockers. Conversely, patients with no varices or small varices (≤5 mm) continue surveillance efforts by endoscopy to monitor for development of large varices. Unfortunately, endoscopy is costly, requires sedation, is poorly tolerated, is subject to high inter-observer variability, cannot detect other signs or portal hypertension or para-esophageal varices that are at risk for future bleeding events, and is associated with risks that include bleeding, esophageal injury and aspiration. Many of these factors contribute to poor patient compliance with AASLD recommendations.

Noninvasive methods for detecting, grading, and risk stratification of esophageal varices are needed. Imaging tests such as ultrasound elastography to measure liver stiffness have been proposed as a method to predict the presence of varices but have insufficient accuracy to eliminate the need for endoscopy.10 An ideal biomarker to screen for esophageal varices would be part of the routine standard of care of patients with cirrhosis, noninvasive, rapid, less expense than endoscopy, highly accurate, highly reproducible, and would require no sedation, provide a quantitative measure of the size of the varices, provide a mechanisms to assess the risk of future bleeding, allow for an assessment for other signs of portal hypertension, and provide other benefits to the patient (e.g. detect ascites and HCC and assess liver vasculature).

Computed tomography (CT) is standard of care to screen for HCC. CT is noninvasive, rapid, less expensive than endoscopy, requires no sedation, provides a quantitative measure of the size of the varices, and allows for assessment of para-esophageal varices, varices in other body locations, ascites, other signs of portal hypertension, patency of liver vasculature, and detection, diagnosis and staging of HCC. Conventional Single-Energy CT (SECT) has relatively high accuracy in prospective studies for detection of any and large varices and has higher inter-observer agreement than endoscopy (kappa 0.56 vs. 0.36, respectively). Major deficiencies in SECT include relatively suboptimal contrast opacification of gastroesophageal varices, inconsistent accuracy that is dependent upon SECT image acquisition technique, and suboptimal stratification of the risk of bleeding (e.g. inability to detect red wale sign) compared to endoscopy.

Dual-Energy CT (DECT) improves the contrast-to-noise ratio by 60% compared to SECT. DECT also improves visualization by taking advantage of the markedly increased attenuation of iodine at photon energy levels just above the iodine K edge (33 keV). Using material decomposition techniques, DECT can map the concentration of iodine on a voxel by voxel basis which, combined with higher contrast to noise resolution on these same type of images, improves the conspicuity of enhancing structures. DECT is routinely used to screen for HCC in cirrhotic patients.

While DECT has been shown to improve image quality and portal venography compared to SECT, the accuracy of DECT for screening for varices has not been reported. The primary objective is to determine the accuracy of dual energy CT for detecting any varices and high-risk varices in patients with cirrhosis presenting for upper gastrointestinal endoscopy.

Being tested
Duel Energy CT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Duel Energy CTDiagnostic test

    Enrolled subjects will complete a dual energy ct for evaluation of esophageal varices

Study groups in NCT03910413
Study groupRoleWhat they receive
Dual Energy CTOtherNot described
Receives: Diagnostic Test: Duel Energy CT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Measure the Accuracy of Dual Energy CT for Detecting Any Varices and High-risk Varices in Patients With Cirrhosis Presenting for Upper Gastrointestinal Endoscopy.

    Varices on dual energy CT will be graded as follows: 0 = no varices, 1 = small [<5 mm] varices, and 2 = large / high risk [>= 5 mm] varices. The reference standard for this outcome will be grading of varices on endoscopy (0 = no varices, 1 = small (< 5 mm) varices, and 2 = large (>=5 mm) varices.

    Measured: DECT will be no more than 2 weeks from the time of endoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2019
  2. Study start5 Jun 2019
  3. Primary completion25 Sep 2019
  4. Study completion6 Jul 2023

Why it stopped: Funding ended and enrollment challenged by COVID and other factors.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03910413
Sponsor's protocol ID
R18-098
Status last verified
Aug 2023
First submitted
4 Apr 2019
Last updated
14 Aug 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Duel Energy CT in people with Gastroesophageal Varices, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Measure the Accuracy of Dual Energy CT for Detecting Any Varices and High-risk Varices in Patients With Cirrhosis Presenting for Upper Gastrointestinal Endoscopy. (time frame: DECT will be no more than 2 weeks from the time of endoscopy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.

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