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

NCT03910413 | Terminated Results FDA Device

• 1 other identifier: R18-098
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Varices

Outcome Measures

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.

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

Study Arms (1)

Dual Energy CT

OTHER

Diagnostic Test: Duel Energy CT

Interventions

Duel Energy CT DIAGNOSTIC_TEST

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

Dual Energy CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital Outpatient Imaging, Leeds and Gardendale locations

Birmingham, Alabama, 35294, United States

Location

Results Point of Contact

• Title: Andrew Smith
• Organization: The University of Alabama at Birmingham

andrewdennissmith@uabmc.edu

205-934-4080

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 10, 2019
• Study Start: June 5, 2019
• Primary Completion: September 25, 2019
• Study Completion: July 6, 2023
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-08

Locations

US (1)