Status:

COMPLETED

CHESS Criteria for Varices Screening in Compensated Advanced Chronic Liver Disease (CHESS2001/APPHA2001)

Lead Sponsor:

Hepatopancreatobiliary Surgery Institute of Gansu Province

Collaborating Sponsors:

LanZhou University

Tianjin Second People's Hospital

Conditions:

Compensated Advanced Chronic Liver Disease

Varices Needing Treatment

Eligibility:

All Genders

18-75 years

Brief Summary

Variceal hemorrhage is the serious complication in patients with compensated advanced chronic liver disease (cACLD). To evaluate the bleeding risk of varices in cACLD, esophagogastroduodenoscopy (EGD)...

Detailed Description

Variceal hemorrhage is the serious complication in patients with compensated advanced chronic liver disease (cACLD). To evaluate the bleeding risk of varices in cACLD, esophagogastroduodenoscopy (EGD)...

Eligibility Criteria

Inclusion

  • age 18-75 years;
  • confirmed cirrhosis based on liver biopsy or clinical findings;
  • without decompensated events (e.g. ascites, bleeding, or overt encephalopathy);
  • scheduled to undergo esophagogastroduodenoscopy, and liver stiffness measurement;
  • estimated survival time\>24 months, and model for end-stage liver disease score\<19, and without liver transplant;
  • with written informed consent.

Exclusion

  • contradictions for esophagogastroduodenoscopy;
  • accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation);
  • Child-Pugh score\>9;
  • time frame between liver stiffness and esophagogastroduodenoscopy\>14 days;
  • diagnosed as hepatocellular carcinoma or other hepatobiliary and pancreatic malignancies;
  • splenectomy or hepatectomy;
  • portal vein thrombosis or cavernous transformation of portal vein;
  • pregnancy or unknown pregnancy status.

Key Trial Info

Start Date :

March 18 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 17 2023

Estimated Enrollment :

2000 Patients enrolled

Trial Details

Trial ID

NCT04307264

Start Date

March 18 2020

End Date

March 17 2023

Last Update

April 25 2023

Active Locations (15)

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Page 1 of 4 (15 locations)

1

Ankang Central Hospital

Ankang, China

2

Beijing Tsinghua Changgung Hospital

Beijing, China

3

the Seventh Medical Center of PLA General Hospital

Beijing, China

4

Dalian Sixth People's Hospital

Dalian, China