Brief Summary

Esophageal varices (EVs) resulting from portal hypertension are a prevalent complication of cirrhosis with a high mortality when variceal hemorrhage (VH) occurs. Screening endoscopy for EVs is recommended for all patients with cirrhosis, and prophylactic treatments are proposed for preventing VH, which may be financially onerous. Therefore, noninvasive tools for diagnosing EVs and risk stratifying VH in cirrhotic patients are needed to decrease the number of unnecessary invasive endoscopic examinations of low-risk patients and avoid unneeded prophylactic treatment. This is a prospective, multi-center diagnostic trial conducted at 9 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based surrogate (rEndosc) (investigational technology) by CT imaging for noninvasive prediction of EVs and risk stratification of VH in patients with hepatitis B virus-related cirrhosis using endoscopic examinations as reference standard.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Timeline

Completed

Started Dec 2017

Geographic Reach

1 country

9 active sites

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

December 5, 2017

Completed

9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed

4 days until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed

Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

December 5, 2017

Last Update Submit

June 16, 2019

Conditions

Esophageal Varices in Cirrhosis of the Liver

Keywords

Esophageal VaricesVariceal HemorrhageEndoscopyRadiomicsHepatitis B Virus

Outcome Measures

Primary Outcomes (1)

Diagnostic Accuracy of rEndosc for Esophageal Varices
Diagnostic accuracy of rEndosc to determine the presence or absence of esophageal varices when compared to endoscopic examination as the reference standard
1 day

Secondary Outcomes (2)

Diagnostic Accuracy of rEndosc for the Risk of Variceal Hemorrhage
1 day
Diagnostic Accuracy of rEndosc for Variceal Hemorrhage
1 day

Study Arms (1)

Single arm study

EXPERIMENTAL

Patients will receive CTA, Endoscopy, and rEndosc per protocol. Intervention: Procedure: Endoscopy

Procedure: EndoscopyProcedure: CTA

Interventions

EndoscopyPROCEDURE

Endoscopy

Single arm study

CTAPROCEDURE

Radiomic features were extracted from CTA images.

Single arm study

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years;
HBsAg positive;
confirmed cirrhosis based on results of histologic examination of liver tissue or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver on ultrasonography, CT, or MR imaging.

You may not qualify if:

active alcohol abuse (less than 6 months of alcohol abstinence); portal thrombosis;
history of treatments for portal hypertension (drug therapy, such as β-blocker, vasopressin) within 2 weeks;
prior surgeries (such as splenectomy, partial splenic embolization/devascularization, transjugular intrahepatic portosystemic shunt);
prior endoscopic therapies (such as endoscopic variceal ligation);
previous variceal hemorrhage;
acute-on-chronic (sub-acute) liver failure;
malignant tumor (such as hepatocellular carcinoma);
cirrhotic portal hypertension with isolated gastric varices or ectopic varices;
inability to adhere to study procedures (such as heart failure, renal failure);
pregnancy or unknown pregnancy status;
no informed consent.

Contact the study team to confirm eligibility.