- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419724
Construction of a Portal Hypertension Biobank
Construction of a Biobank for a Specialized Cohort of Portal Hypertension
Esophageal and gastric variceal bleeding (EGVB) is a severe complication of portal hypertension (PH), characterized by high bleeding volume, high rebleeding rate, and high mortality. In recent years, endoscopic treatment has significantly improved therapeutic efficacy and patient survival. However, due to substantial individual variations among patients, individualized stratified management is crucial. For special populations with cirrhotic portal hypertension, clear management guidelines and clinical research evidence are lacking. The incidence of non-cirrhotic portal hypertension is increasing year by year; it has complex etiologies, lacks specific symptoms and imaging features, and poses diagnostic challenges. Currently, multi-omics research on portal hypertension is insufficient. The integration of multi-omics technologies, including genomics, radiomics, metabolomics, and gut microbiota, holds promise for a more comprehensive understanding of the pathogenesis. With continuous improvements in multi-modal medical data fusion technology, there is an urgent need to develop clinical decision support systems by combining standardized multi-omics databases with artificial intelligence techniques, thereby enhancing clinical decision-making capabilities and prognostic assessment.
This study aims to expand the established portal hypertension biobank by extending the temporal depth of clinical cohort data and diversifying sample types.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiaoquan Huang, M.D.
- Phone Number: 86-18801733835
- Email: huang.xiaoquan@zs-hospital.sh.cn
Study Locations
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200000
- Recruiting
- Zhongshan Hospital, Fudan University
-
Contact:
- Xiaoquan Huang, M.D.
- Phone Number: 86-18801733835
- Email: huang.xiaoquan@zs-hospital.sh.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinically diagnosed with portal hypertension complicated by esophagogastric varices.
- Underwent abdominal CT examination
Exclusion Criteria:
- Imaging or endoscopic evidence demonstrating absence of esophageal and/or gastric varices.
- CT image quality not meeting requirements or incomplete medical history data.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cirrhotic
Patients with portal hypertension who present with liver Cirrhosis.
|
Endoscopic treatment including ligation and cyanoacrylate injection
|
|
Non-cirrhotic
Patients with portal hypertension who present with-out liver Cirrhosis.
|
Endoscopic treatment including ligation and cyanoacrylate injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
One-year rebleeding
Time Frame: Within 1 year
|
Within 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Death
Time Frame: Within 1 year
|
Within 1 year
|
|
|
Complications
Time Frame: Within 1 year
|
Portal hypertension-related complications (including ascites, hepatic encephalopathy, portal vein thrombosis, etc.)
|
Within 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2025-327R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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