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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Varices in Cirrhosis of the Liver
• Intervention / Treatment: Procedure: CTA; Procedure: Endoscopy

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Chinese PLA General hospital
    • Beijing, Beijing, China
      • Beijing Youan Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Peking University People's Hospital
    • Beijing, Beijing, China
      • 302 Hospital of PLA
    • Beijing, Beijing, China
      • Beijing Friendship Hospital, Capital Medical University
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated Hospital of Chongqing Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Nanfang Hospital, Southern Medical University
  • Hebei
    • Xingtai, Hebei, China
      • Xingtai People's Hospital
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Single arm study; Patients will receive CTA, Endoscopy, and rEndosc per protocol. Intervention: Procedure: Endoscopy	Procedure: CTA; Radiomic features were extracted from CTA images.; Procedure: Endoscopy; Endoscopy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Peking University People's Hospital; Beijing Friendship Hospital; Beijing YouAn Hospital; Beijing 302 Hospital; Chinese PLA General Hospital; Shandong Provincial Hospital; The Second Affiliated Hospital of Chongqing Medical University; Xingtai People's Hospital
• Investigators: Principal Investigator: Huiguo Ding, M.D., Beijing YouAn Hospital

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Hepatology. 2017 Jul;66(1):304.
• 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.
• Segal E, Sirlin CB, Ooi C, Adler AS, Gollub J, Chen X, Chan BK, Matcuk GR, Barry CT, Chang HY, Kuo MD. Decoding global gene expression programs in liver cancer by noninvasive imaging. Nat Biotechnol. 2007 Jun;25(6):675-80. doi: 10.1038/nbt1306. Epub 2007 May 21.
• Lambin P, Leijenaar RTH, Deist TM, Peerlings J, de Jong EEC, van Timmeren J, Sanduleanu S, Larue RTHM, Even AJG, Jochems A, van Wijk Y, Woodruff H, van Soest J, Lustberg T, Roelofs E, van Elmpt W, Dekker A, Mottaghy FM, Wildberger JE, Walsh S. Radiomics: the bridge between medical imaging and personalized medicine. Nat Rev Clin Oncol. 2017 Dec;14(12):749-762. doi: 10.1038/nrclinonc.2017.141. Epub 2017 Oct 4.
• 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. Erratum In: J Clin Oncol. 2016 Jul 10;34(20):2436.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2017
• Primary Completion (ANTICIPATED): December 18, 2018
• Study Completion (ANTICIPATED): December 18, 2018

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (ACTUAL): December 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 16, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Endoscopy; Hepatitis B Virus; Esophageal Varices; Radiomics; Variceal Hemorrhage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Fibrosis; Liver Cirrhosis; Esophageal and Gastric Varices
• Other Study ID Numbers: CHESS1703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No