Treatment Outcomes for Portal Hypertension Esophageal and Gastric Varices

May 12, 2026 updated by: Shanghai Zhongshan Hospital

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1384

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Clinical diagnosis of portal hypertension with esophagogastric varices.
  • Underwent abdominal CT and gastroscopy examinations.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Endoscopic treatment group
Patients who receive endoscopic treatment
Non-endoscopic treatment group
Patients who received alternative treatments (excluding endoscopic therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: At 1, 2, 6, and 12 months post-treatment
Survival status
At 1, 2, 6, and 12 months post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: At 1, 2, 6, and 12 months post-treatment
Post-treatment adverse events included rebleeding (and its causes), hepatic encephalopathy, and ascites
At 1, 2, 6, and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Principal Investigator: Shiyao Chen, Ph.D., Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2025-366

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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