CClinicalTrials.gg
TerminatedNCT03910413Updated Aug 14, 2023Results posted

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

An interventional study of Duel Energy CT in Gastroesophageal Varices, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Funding ended and enrollment challenged by COVID and other factors.
Phase
Not applicable
Study type
Interventional
Enrollment
11
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Gastroesophageal Varices
03

In context

Esophageal and Gastric Varices

169 studies on the registry are indexed under Esophageal and Gastric Varices; 41 are open to participants now.

This study's enrollment of 11 is below the median of 104 across 109 interventional studies indexed under Esophageal and Gastric Varices.

Browse Esophageal and Gastric Varices studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Other
    Dual Energy CT

    Diagnostic Test: Duel Energy CT

Interventions

  • Diagnostic testDuel Energy CT

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

06

What researchers measure

Primary outcomes

  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.

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

07

Results

Posted Aug 14, 2023

Participant flow

Participant flow — Overall Study
MilestoneDual Energy CT
Started11
Completed6
Not completed5

Outcome measures

PrimaryTo 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.

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

No measurements were reported for this outcome.

Adverse events

Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dual Energy CT0/11 (0%)0/11 (0%)0/11 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dual Energy CT
<=18 years0
Between 18 and 65 years10
>=65 years1
Age, Continuous
Age, Continuous(years)Dual Energy CT
Median59 (31 to 65)
Sex: Female, Male
Sex: Female, Male(Participants)Dual Energy CT
Female6
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dual Energy CT
Hispanic or Latino0
Not Hispanic or Latino11
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dual Energy CT
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White8
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • UAB Hospital Outpatient Imaging, Leeds and Gardendale locations
    Birmingham, Alabama 35294, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 22, 2023

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03910413
Lead sponsor
University of Alabama at Birmingham
Responsible party
Andrew Dennis Smith (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Apr 10, 2019
Start date
Jun 5, 2019
Primary completion
Sep 25, 2019
Completion
Jul 6, 2023
Results posted
Aug 14, 2023
Last update
Aug 14, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion