Esophagogastric VaricesNCT07358663
Treatment Outcomes for Portal Hypertension Esophageal and Gastric Varices
An observational study of Esophagogastric Varices and Portal Hypertension, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This study is a single-center, prospective cohort study based on real-world data. Patients with portal hypertension and esophagogastric varices were enrolled and divided into an endoscopic treatment group and a non-endoscopic treatment group (including patients receiving medical therapy, interventional procedures, or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagogastric Varices, Portal Hypertension
- How many people
- 1,384 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 31 Dec 2028
- 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 with portal hypertension and esophagogastric varices between January 2026 and December 2027 were included. Portal hypertension was defined as elevated portal pressure caused by various etiologies, including chronic viral hepatitis, metabolic-associated fatty liver disease, autoimmune liver disease, chemotherapy-induced liver injury, and hematological disorders. The diagnosis of portal hypertension and esophagogastric varices was confirmed by laboratory tests and imaging studies.
Who may be able to join
- Clinical diagnosis of portal hypertension with esophagogastric varices.
- Underwent abdominal CT and gastroscopy examinations.
Who cannot join
- Presence of peptic ulcer, gastric tumor, or other causes of gastrointestinal bleeding confirmed by imaging or gastroscopy.
- CT images of inadequate quality 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
Xiaoquan Huang, M.D., 18801733835, huang.xiaoquan@zs-hospital.sh.cn
About this study
Official title: Assessment of Treatment Outcomes for Esophageal and Gastric Varices Secondary to Portal Hypertension
This study is a single-center, prospective cohort study based on real-world data. Patients with portal hypertension and esophagogastric varices were enrolled and divided into an endoscopic treatment group and a non-endoscopic treatment group (including patients receiving medical therapy, interventional procedures, or surgical treatment) according to whether they underwent endoscopic intervention. Baseline data, serum metabolites, CT imaging and endoscopic images, liver biopsy pathology, and other multi-omics data were integrated for both groups. Patients were followed up to compare adverse events after variceal treatment, including rebleeding and its causes, hepatic encephalopathy, ascites, subsequent treatments (such as regular endoscopic therapy, NSSB, and TIPS), and survival outcomes. Clinical characteristics of portal hypertension attributed to different etiologies, including hepatitis B, autoimmune liver disease, schistosomiasis, hematological disorders, and chemotherapy-induced liver injury, were compared. The efficacy and safety of endoscopic and interventional treatments for esophagogastric varices were evaluated. Factors influencing rebleeding rates among different treatment groups were analyzed, and reasons for inclusion in different groups were discussed.
- Conditions
- Esophagogastric Varices, Portal Hypertension
- Keywords
- endoscopic treatment, portal hypertension
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment group | Patients who receive endoscopic treatment | |
| Non-endoscopic treatment group | Patients who received alternative treatments (excluding endoscopic therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival status
Measured: At 1, 2, 6, and 12 months post-treatment
Secondary outcomes (1)
Adverse events
Post-treatment adverse events included rebleeding (and its causes), hepatic encephalopathy, and ascites
Measured: At 1, 2, 6, and 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start20 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagogastric VaricesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiyao Chen, Ph.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358663
- Sponsor's protocol ID
- B2025-366
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Treatment Outcomes for Esophageal and Gastric Varices Secondary to Portal Hypertension
- ClinicalTrials.gov ID
- NCT07358663
- Acronym / sponsor ID
- B2025-366
- Conditions
- Esophagogastric Varices, Portal Hypertension
- Keywords
- endoscopic treatment, portal hypertension
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,384 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jan 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.
This study is a single-center, prospective cohort study based on real-world data. Patients with portal hypertension and esophagogastric varices were enrolled and divided into an endoscopic treatment group and a non-endoscopic treatment group (including patients receiving medical therapy, interventional procedures, or surgical treatment) according to whether they underwent endoscopic intervention. Baseline data, serum metabolites, CT imaging and endoscopic images, liver biopsy pathology, and other multi-omics data were integrated for both groups. Patients were followed up to compare adverse events after variceal treatment, including rebleeding and its causes, hepatic encephalopathy, ascites, subsequent treatments (such as regular endoscopic therapy, NSSB, and TIPS), and survival outcomes. Clinical characteristics of portal hypertension attributed to different etiologies, including hepatitis B, autoimmune liver disease, schistosomiasis, hematological disorders, and chemotherapy-induced liver injury, were compared. The efficacy and safety of endoscopic and interventional treatments for esophagogastric varices were evaluated. Factors influencing rebleeding rates among different treatment groups were analyzed, and reasons for inclusion in different groups were discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment group | – | –Patients who receive endoscopic treatment |
| Non-endoscopic treatment group | – | –Patients who received alternative treatments (excluding endoscopic therapy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with portal hypertension and esophagogastric varices between January 2026 and December 2027 were included. Portal hypertension was defined as elevated portal pressure caused by various etiologies, including chronic viral hepatitis, metabolic-associated fatty liver disease, autoimmune liver disease, chemotherapy-induced liver injury, and hematological disorders. The diagnosis of portal hypertension and esophagogastric varices was confirmed by laboratory tests and imaging studies.
Key inclusion criteria (2 listed)
- Clinical diagnosis of portal hypertension with esophagogastric varices.
- Underwent abdominal CT and gastroscopy examinations.
Key exclusion criteria (2 listed)
- Presence of peptic ulcer, gastric tumor, or other causes of gastrointestinal bleeding confirmed by imaging or gastroscopy.
- CT images of inadequate quality 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.
Primary outcome
Survival
Time frame: At 1, 2, 6, and 12 months post-treatment
Survival status
1 secondary outcome
Adverse events
Time frame: At 1, 2, 6, and 12 months post-treatment
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 14 May 2026.
Related trials for Esophagogastric Varices
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Hepatic and Splenic Microcirculatory Perfusion for Ruling Out High-Risk Varices in Patients With Hepatitis B-Related Cirrhosis
Hepatitis B Virus Related Cirrhosis, Portal Hypertension Related to Cirrhosis
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EUS-PPG Alteration After Ligation and Sclerotherapy in Esophageal Varices
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Feasibility and Safety Evaluation of Endoscopic Treatment of Esophagogastric Varices in Cirrhosis on the Day-care Unit
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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.
Shiyao Chen, Ph.D. principal investigator
Fudan University
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 Esophagogastric Varices 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 14 May 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?
Survival (time frame: At 1, 2, 6, and 12 months post-treatment). 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 14 May 2026.