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NCT03910413 · ClinicalTrials.gov registry record · NA
Dual Energy CT as a Noninvasive Method to Screen for Gastroesophageal Varices
A NA study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03910413: Clinical Trial NA study, sponsored by University of Alabama at Birmingham.
NCT03910413 is a NA study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03910413, a NA study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- DIAGNOSTIC_TEST Duel Energy CT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2019-06-05 |
| Est. Completion | 2023-07-06 |
| Phase | NA |
Why NCT03910413 stopped before completion
NCT03910413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Duel Energy CT is the first listed.
NCT03910413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03910413 about?
NCT03910413 is a clinical study titled "Dual Energy CT as a Noninvasive Method to Screen for Gastroesophageal Varices". 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 gastr...
What is the current status of trial NCT03910413?
This trial is currently terminated. It is a NA study. The enrollment target is 11 participants. The study started on 2019-06-05. Estimated completion is 2023-07-06.
What interventions are being tested in trial NCT03910413?
The interventions under investigation include: Duel Energy CT (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03910413?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03910413's enrollment target sits among peer trials
11 1927th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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