Trial Outcomes & Findings for Dual Energy CT as a Noninvasive Method to Screen for Gastroesophageal Varices (NCT NCT03910413)

NCT ID: NCT03910413

Last Updated: 2023-08-14

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: DECT will be no more than 2 weeks from the time of endoscopy
• Results posted on: 2023-08-14

Participant Flow

Participant milestones

Measure	Dual Energy CT Duel Energy CT: Enrolled subjects will complete a dual energy ct for evaluation of esophageal varices
Overall Study STARTED	11
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dual Energy CT n=11 Participants Duel Energy CT: Enrolled subjects will complete a dual energy ct for evaluation of esophageal varices
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

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

Population: The study was ended prematurely due to covid. This data was not collected.

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.

Outcome measures

Outcome data not reported

Adverse Events

Dual Energy CT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Smith

The University of Alabama at Birmingham

Phone: 205-934-4080

Email: andrewdennissmith@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place