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Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)

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ClinicalTrials.gov Identifier: NCT03713606
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborators:
Beijing YouAn Hospital
Shandong Provincial Hospital
Beijing Shijitan Hospital
Beijing Friendship Hospital
Xingtai People's Hospital
Beijing 302 Hospital
Information provided by (Responsible Party):
Xiaolong Qi, Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment
Hypertension, Portal Procedure: HVPG measurement

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.

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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Biomarkers Associated With Endothelial Dysfunction and Immune Inflammation for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
Actual Study Start Date : September 30, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : February 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
Overall eligible participants
Eligible participants will receive HVPG measurement by catheterization of a hepatic vein with a balloon catheter and run blood tests.
Procedure: HVPG measurement
HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
Other Name: Blood test




Primary Outcome Measures :
  1. Correlation between serum biomarkers and HVPG [ Time Frame: 1 day ]
    Correlation between serum biomarkers and HVPG


Secondary Outcome Measures :
  1. Correlation between serum biomarkers and HVPG in HBV subgroup [ Time Frame: 1 day ]
    Correlation between serum biomarkers and HVPG in a subgroup of patients with HBV-related cirrhosis


Biospecimen Retention:   Samples Without DNA
Blood serum


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cirrhotic portal hypertension
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713606


Contacts
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Contact: Xiaolong Qi, M.D. +86 18588602600 qixiaolong@vip.163.com
Contact: Yanna Liu +86 15625076784 lauyenna@126.com

Locations
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China
302 Hospital of PLA Recruiting
Beijing, China
Contact: Ruizhao Qi, MD         
Principal Investigator: Ruizhao Qi, MD         
Beijing Friendship Hospital Recruiting
Beijing, China
Contact: Yu Wang, MD         
Principal Investigator: Yu Wang, MD         
Beijing Shijitan Hospital Recruiting
Beijing, China
Contact: Fuquan Liu, MD         
Principal Investigator: Fuquan Liu, MD         
Beijing YouAn Hospital Recruiting
Beijing, China
Contact: Huiguo Ding, MD         
Principal Investigator: Huiguo Ding, MD         
Shandong Provincial Hospital Recruiting
Jinan, China
Contact: Chunqing Zhang, MD         
Principal Investigator: Chunqing Zhang, MD         
Xingtai People's Hospital Recruiting
Xingtai, China
Contact: Dengxiang Liu, MD         
Principal Investigator: Dengxiang Liu, MD         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Beijing YouAn Hospital
Shandong Provincial Hospital
Beijing Shijitan Hospital
Beijing Friendship Hospital
Xingtai People's Hospital
Beijing 302 Hospital
Investigators
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Principal Investigator: Xiaolong Qi, M.D. Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Xiaolong Qi, Director, Hepatic Hemodynamic Lab, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03713606     History of Changes
Other Study ID Numbers: Pan-CHESS1802
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaolong Qi, Nanfang Hospital of Southern Medical University:
Portal hypertension
serum biomarker
diagnosis
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases