Radiomics-based Surrogate of Endoscopy (rEndosc) (CHESS1703)
NCT03373123 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-06-19
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.
Conditions
- Esophageal Varices in Cirrhosis of the Liver
Interventions
- PROCEDURE
-
Endoscopy
Endoscopy
- PROCEDURE
-
CTA
Radiomic features were extracted from CTA images.
Sponsors & Collaborators
-
Beijing YouAn Hospital
collaborator OTHER -
Beijing 302 Hospital
collaborator OTHER -
Shandong Provincial Hospital
collaborator OTHER_GOV -
Beijing Friendship Hospital
collaborator OTHER -
The Second Affiliated Hospital of Chongqing Medical University
collaborator OTHER -
Chinese PLA General Hospital
collaborator OTHER -
Peking University People's Hospital
collaborator OTHER -
Xingtai People's Hospital
collaborator OTHER -
Nanfang Hospital, Southern Medical University
lead OTHER
Principal Investigators
-
Huiguo Ding, M.D. · Beijing YouAn Hospital
-
Xiaolong Qi, M.D. · Nanfang Hospital, Southern Medical University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-12-18
- Primary Completion
- 2018-12-18
- Completion
- 2018-12-18
Countries
- China
Study Locations
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