Clinical trial NCT03373123: Radiomics-based Surrogate of Endoscopy (rEndosc) (CHESS1703)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophageal Varices in Cirrhosis of the Liver
Keywords: Esophageal Varices
Variceal Hemorrhage
Endoscopy
Radiomics
Hepatitis B Virus
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: Beijing 302 Hospital
name: Shandong Provincial Hospital
name: Beijing Friendship Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
name: Chinese PLA General Hospital
name: Peking University People's Hospital
name: Xingtai People's Hospital
First posted: 2017-12-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Diagnostic Accuracy of rEndosc for Esophageal Varices
timeFrame: 1 day
Secondary outcomes:
measure: Diagnostic Accuracy of rEndosc for the Risk of Variceal Hemorrhage
timeFrame: 1 day
measure: Diagnostic Accuracy of rEndosc for Variceal Hemorrhage
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Hospital of PLA
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Beijing YouAn Hospital
name: Huiguo Ding, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaolong Qi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
citation: de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
citation: Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
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citation: Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.2015.65.9128. Epub 2016 May 2.