Construction of a Portal Hypertension Biobank

NCT07419724 | Recruiting

• 1 other identifier: B2025-327R
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Variceal Bleeding; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• One-year rebleeding

  Within 1 year

Secondary Outcomes (2)

• Death

  Within 1 year

• Complications

  Within 1 year

Study Arms (2)

Cirrhotic

Patients with portal hypertension who present with liver Cirrhosis.

Procedure: Endoscopic treatment

Non-cirrhotic

Patients with portal hypertension who present with-out liver Cirrhosis.

Procedure: Endoscopic treatment

Interventions

Endoscopic treatment PROCEDURE

Endoscopic treatment including ligation and cyanoacrylate injection

Cirrhotic; Non-cirrhotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for portal hypertension with esophagogastric varices from September 2025 to December 2028.

You may qualify if:

• Clinically diagnosed with portal hypertension complicated by esophagogastric varices.
• Underwent abdominal CT examination

You may not qualify if:

• Imaging or endoscopic evidence demonstrating absence of esophageal and/or gastric varices.
• CT image quality not meeting requirements or incomplete medical history data.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biological samples to be collected include: 1,000 blood samples, 600 fecal samples, and 60 liver biopsy specimens.

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Central Study Contacts

Xiaoquan Huang, M.D.

CONTACT

86-18801733835; huang.xiaoquan@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: October 16, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 19, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)