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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 is a NA study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 11 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03910413
The ClinicalTrials.gov registry entry for NCT03910413 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Duel Energy CT is the first listed.
NCT03910413 reports 0 study locations.
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.
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