Clinical trial NCT03713606: Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Official title: Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension, Portal
Keywords: Portal hypertension
serum biomarker
diagnosis
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Beijing YouAn Hospital
name: Shandong Provincial Hospital
name: Beijing Shijitan Hospital, Capital Medical University
name: Beijing Friendship Hospital
name: Xingtai People's Hospital
name: Beijing 302 Hospital
First posted: 2018-10-22
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic portal hypertension

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.

Detailed description: Hepatic venous pressure gradient (HVPG) is the gold standard for assessing portal pressure, of which the measurement is invasive and therefore not suitable for routine clinical practice. The detection of serum biomarkers is potential for noninvasive diagnosis of portal hypertension in cirrhosis. However, many are still in the exploratory phases of testing and are not yet ready to enter clinical practice. This study prospectively enrolled participants in 6 liver centers (Beijing YouAn Hospital, Shandong Provincial Hospital, Beijing Shijitan Hospital, Beijing Friendship Hospital, Xingtai People's Hospital, and 302 Hospital of PLA) in China designed to study the correlation between serum biomarkers associated with endothelial dysfunction and immune inflammation and HVPG in cirrhosis.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Correlation between serum biomarkers and HVPG
timeFrame: 1 day
Secondary outcomes:
measure: Correlation between serum biomarkers and HVPG in HBV subgroup
timeFrame: 1 day
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Hospital of PLA
city: Beijing
country: China
facility: Beijing Friendship Hospital
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Beijing
country: China
facility: Beijing YouAn Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Xingtai
country: China
facility: Xingtai People's Hospital
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Xiaolong Qi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Waidmann 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.
citation: Buck 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.
citation: Ferlitsch 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.
citation: Qi 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.