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

Nanfang Hospital, Southern Medical University

Status

Withdrawn

Conditions

Esophageal Varices in Cirrhosis of the Liver

Treatments

Procedure: CTA

Procedure: Endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT03373123

CHESS1703

Details and patient eligibility

About

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.

Full description

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.

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.