Variceal BleedingNCT07419724
Construction of a Portal Hypertension Biobank
An observational study of Variceal Bleeding and Portal Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Variceal Bleeding, Portal Hypertension
- What is being tested?
- Endoscopic treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2025to 31 Dec 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for portal hypertension with esophagogastric varices from September 2025 to December 2028.
Who may be able to join
- Clinically diagnosed with portal hypertension complicated by esophagogastric varices.
- Underwent abdominal CT examination
Who cannot join
- Imaging or endoscopic evidence demonstrating absence of esophageal and/or gastric varices.
- CT image quality not meeting requirements or incomplete medical history data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Xiaoquan Huang, M.D., 86-18801733835, huang.xiaoquan@zs-hospital.sh.cn
About this study
Official title: 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.
- Conditions
- Variceal Bleeding, Portal Hypertension
- Being tested
- Endoscopic treatment
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic treatmentProcedure or surgery
Endoscopic treatment including ligation and cyanoacrylate injection
| Study group | Role | What they receive |
|---|---|---|
| Cirrhotic | Patients with portal hypertension who present with liver Cirrhosis. Receives: Procedure: Endoscopic treatment | |
| Non-cirrhotic | Patients with portal hypertension who present with-out liver Cirrhosis. Receives: Procedure: Endoscopic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year rebleeding
Measured: Within 1 year
Secondary outcomes (2)
Death
Measured: Within 1 year
Complications
Portal hypertension-related complications (including ascites, hepatic encephalopathy, portal vein thrombosis, etc.)
Measured: Within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start16 Oct 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variceal BleedingStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419724
- Sponsor's protocol ID
- B2025-327R
- Status last verified
- Jun 2025
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of a Biobank for a Specialized Cohort of Portal Hypertension
- ClinicalTrials.gov ID
- NCT07419724
- Acronym / sponsor ID
- B2025-327R
- Conditions
- Variceal Bleeding, Portal Hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cirrhotic | – | Procedure: Endoscopic treatmentPatients with portal hypertension who present with liver Cirrhosis. |
| Non-cirrhotic | – | Procedure: Endoscopic treatmentPatients with portal hypertension who present with-out liver Cirrhosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for portal hypertension with esophagogastric varices from September 2025 to December 2028.
Key inclusion criteria (2 listed)
- Clinically diagnosed with portal hypertension complicated by esophagogastric varices.
- Underwent abdominal CT examination
Key exclusion criteria (2 listed)
- Imaging or endoscopic evidence demonstrating absence of esophageal and/or gastric varices.
- CT image quality not meeting requirements or incomplete medical history data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic treatmentEndoscopic treatment including ligation and cyanoacrylate injection | Procedure or surgery | Cirrhotic, Non-cirrhotic |
Primary outcome
One-year rebleeding
Time frame: Within 1 year
2 secondary outcomes
Death
Time frame: Within 1 year
Complications
Time frame: Within 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Variceal Bleeding and Portal Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoquan Huang, M.D. (86-18801733835, huang.xiaoquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year rebleeding (time frame: Within 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.