Radiomics-based Surrogate of Endoscopy (rEndosc) (CHESS1703)

Nanfang Hospital, Southern Medical University

Overview

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.

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 (Beijing YouAn Hospital, Capital Medical University; Nanfang Hospital, Southern Medical University; 302 Hospital of PLA; Shandong Provincial Hospital; Beijing Friendship Hospital, Capital Medical University; Chinese PLA General Hospital; Peking University People's Hospital; Xingtai People's Hospital) 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Conditions

Esophageal Varices in Cirrhosis of the Liver

Interventions

EndoscopyPROCEDURE

Endoscopy

CTAPROCEDURE

Radiomic features were extracted from CTA images.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 18-75 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. Exclusion Criteria: * 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.

Locations (9)

302 Hospital of PLA

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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

Time frame: 1 day

Secondary Outcomes

Diagnostic Accuracy of rEndosc for the Risk of Variceal Hemorrhage

Diagnostic accuracy of rEndosc to stratify risk of variceal hemorrhage when compared to endoscopic examination as the reference standard

Time frame: 1 day

Diagnostic Accuracy of rEndosc for Variceal Hemorrhage

Diagnostic accuracy of rEndosc to determine the presence or absence of variceal hemorrhage within 1-year follow-up

Time frame: 1 day

Data from ClinicalTrials.gov

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