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

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)

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03373123

Acronym

rEndosc

Enrollment

Registered

2017-12-14

Start date

2017-12-18

Completion date

2018-12-18

Last updated

2019-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Varices in Cirrhosis of the Liver

Keywords

Esophageal Varices, Variceal Hemorrhage, Endoscopy, Radiomics, Hepatitis B Virus

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.

Detailed 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.

Interventions

PROCEDUREEndoscopy

Endoscopy

PROCEDURECTA

Radiomic features were extracted from CTA images.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Diagnostic Accuracy of rEndosc for the Risk of Variceal Hemorrhage	1 day	Diagnostic accuracy of rEndosc to stratify risk of variceal hemorrhage when compared to endoscopic examination as the reference standard
Diagnostic Accuracy of rEndosc for Variceal Hemorrhage	1 day	Diagnostic accuracy of rEndosc to determine the presence or absence of variceal hemorrhage within 1-year follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026