Treatment Outcomes for Portal Hypertension Esophageal and Gastric Varices

NCT07358663 | Recruiting

• 1 other identifier: B2025-366
• Study Type: observational
• Target: 1,384
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival status

  At 1, 2, 6, and 12 months post-treatment

Secondary Outcomes (1)

• Adverse events

  At 1, 2, 6, and 12 months post-treatment

Study Arms (2)

Endoscopic treatment group

Patients who receive endoscopic treatment

Non-endoscopic treatment group

Patients who received alternative treatments (excluding endoscopic therapy)

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 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Shiyao Chen, Ph.D.

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoquan Huang, M.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-01

Locations

CN (1)