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

Esophageal Varices in Cirrhosis of the Liver Clinical Trial

— rEndosc  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03373123
• Other study ID #: CHESS1703
• Status: Withdrawn
• Phase: N/A
• Start date: December 18, 2017
• Est. completion date: December 18, 2018

Study information

• Verified date: June 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices in Cirrhosis of the Liver
• Fibrosis
• Liver Cirrhosis

Intervention

Procedure:
• Endoscopy
Endoscopy
• CTA
Radiomic features were extracted from CTA images.

Locations

Country	Name	City	State
China	302 Hospital of PLA	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Xingtai People's Hospital	Xingtai	Hebei

Sponsors (9)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Beijing 302 Hospital, Beijing Friendship Hospital, Beijing YouAn Hospital, Chinese PLA General Hospital, Peking University People's Hospital, Shandong Provincial Hospital, The Second Affiliated Hospital of Chongqing Medical University, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. Erratum in: Hepatology. 2017 Jul;66(1):304. — View 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. — View 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. Erratum in: J Clin Oncol. 2016 Jul 10;34(20):2436. — View Citation

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. Review. — View Citation

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. Epub 2007 May 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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