Status:

WITHDRAWN

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

Lead Sponsor:

Nanfang Hospital, Southern Medical University

Collaborating Sponsors:

Beijing YouAn Hospital

Beijing 302 Hospital

Conditions:

Esophageal Varices in Cirrhosis of the Liver

Eligibility:

All Genders

18-75 years

Phase:

NA

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 recomme...

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 recomme...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

December 18 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 18 2018

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT03373123

Start Date

December 18 2017

End Date

December 18 2018

Last Update

June 19 2019

Active Locations (9)

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Page 1 of 3 (9 locations)

1

302 Hospital of PLA

Beijing, Beijing Municipality, China

2

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

3

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

4

Chinese PLA General Hospital

Beijing, Beijing Municipality, China