Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
1 other identifier
observational
75
1 country
6
Brief Summary
This is a prospective, multi-center diagnostic trial conducted at 6 liver centers in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and hepatic venous pressure gradient in cirrhosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2018
CompletedFirst Submitted
Initial submission to the registry
October 18, 2018
CompletedFirst Posted
Study publicly available on registry
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedAugust 17, 2021
August 1, 2021
3.3 years
October 18, 2018
August 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Correlation between serum biomarkers and HVPG
Correlation between serum biomarkers and HVPG
1 day
Secondary Outcomes (1)
Correlation between serum biomarkers and HVPG in HBV subgroup
1 day
Study Arms (1)
Overall eligible participants
Eligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests.
Interventions
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
Eligibility Criteria
Cirrhotic portal hypertension
You may qualify if:
- age 18-75 years;
- confirmed cirrhosis based on histologic examination of liver or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver.
You may not qualify if:
- prior drug therapy (e.g. β-blocker, vasopressin) within two weeks
- prior surgeries (e.g. TIPS, partial splenic embolization/ devascularization, splenectomy, liver transplantation)
- non-sinusoidal portal hypertension \& HCC inability to adhere to study procedures
- pregnancy or unknown pregnancy status
- no informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Beijing YouAn Hospitalcollaborator
- Shandong Provincial Hospitalcollaborator
- Beijing Shijitan Hospital, Capital Medical Universitycollaborator
- Beijing Friendship Hospitalcollaborator
- Xingtai People's Hospitalcollaborator
- Beijing 302 Hospitalcollaborator
Study Sites (6)
302 Hospital of PLA
Beijing, China
Beijing Friendship Hospital
Beijing, China
Beijing Shijitan Hospital
Beijing, China
Beijing YouAn Hospital
Beijing, China
Shandong Provincial Hospital
Jinan, China
Xingtai People's Hospital
Xingtai, China
Related Publications (5)
Groszmann RJ, Wongcharatrawee S. The hepatic venous pressure gradient: anything worth doing should be done right. Hepatology. 2004 Feb;39(2):280-2. doi: 10.1002/hep.20062. No abstract available.
PMID: 14767976BACKGROUNDWaidmann O, Brunner F, Herrmann E, Zeuzem S, Piiper A, Kronenberger B. Macrophage activation is a prognostic parameter for variceal bleeding and overall survival in patients with liver cirrhosis. J Hepatol. 2013 May;58(5):956-61. doi: 10.1016/j.jhep.2013.01.005. Epub 2013 Jan 16.
PMID: 23333526BACKGROUNDBuck M, Garcia-Tsao G, Groszmann RJ, Stalling C, Grace ND, Burroughs AK, Patch D, Matloff DS, Clopton P, Chojkier M. Novel inflammatory biomarkers of portal pressure in compensated cirrhosis patients. Hepatology. 2014 Mar;59(3):1052-9. doi: 10.1002/hep.26755. Epub 2014 Jan 29.
PMID: 24115225BACKGROUNDFerlitsch M, Reiberger T, Hoke M, Salzl P, Schwengerer B, Ulbrich G, Payer BA, Trauner M, Peck-Radosavljevic M, Ferlitsch A. von Willebrand factor as new noninvasive predictor of portal hypertension, decompensation and mortality in patients with liver cirrhosis. Hepatology. 2012 Oct;56(4):1439-47. doi: 10.1002/hep.25806. Epub 2012 Aug 27.
PMID: 22532296BACKGROUNDQi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PMID: 30215362BACKGROUND
Biospecimen
Blood serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaolong Qi, M.D.
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Hepatic Hemodynamic Lab
Study Record Dates
First Submitted
October 18, 2018
First Posted
October 22, 2018
Study Start
September 30, 2018
Primary Completion
January 31, 2022
Study Completion
June 1, 2022
Last Updated
August 17, 2021
Record last verified: 2021-08