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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Radiomics-based Surrogate of Endoscopy (rEndosc) for Noninvasive Prediction of Esophageal Varices and Risk Stratification of Variceal Hemorrhage in Hepatitis B Virus-related Cirrhosis (CHESS1703)

Conditions
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Esophageal Varices in Cirrhosis of the Liver

Intervention / Treatment
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* Procedure: Endoscopy
* Procedure: CTA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm study<br>Patients will receive CTA, Endoscopy, and rEndosc per protocol. Intervention: Procedure: Endoscopy | Procedure: Endoscopy<br>* Endoscopy<br>Procedure: CTA<br>* Radiomic features were extracted from CTA images.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal Varices, Variceal Hemorrhage, Endoscopy, Radiomics, Hepatitis B Virus