Evaluation of Endoscopic Treatment Effect Based on HVPG

Evaluation of Endoscopic Treatment Effect and Influencing Factors in Patients With Esophageal and Gastric Varices in Cirrhosis Based on HVPG

This study aims to evaluate the endoscopic treatment effect and related influencing factors of patients with esophageal and gastric varices based on HVPG. By enrolling and collecting patients with esophageal and gastric varices at different stages of liver cirrhosis, the changes in portal pressure before and during endoscopic treatment were detected. The endoscopic treatment effect of different patients was evaluated by combining the changes in HVPG and the condition of varicose veins, the effects of different endoscopic treatment methods on HVPG were analyzed, and the correlation between HVPG changes and endoscopic efficacy was explored.

Study Overview

• Status: Enrolling by invitation
• Conditions: Esophageal and Gastric Varices
• Intervention / Treatment: Procedure: Endoscopic treatment

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Inpatients in gastroenterology department

Description

Inclusion Criteria:

1. Age range: 18-80 years old;
2. Patients with confirmed cirrhosis through clinical, imaging or pathological evidence, with causes including viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, etc.;
3. Patients with esophageal and gastric varices confirmed by endoscopic examination and varicose vein bleeding in the past;
4. Endoscopic treatment (such as band ligation, sclerotherapy or colloid injection) is an appropriate secondary prevention method;

Exclusion Criteria:

• (1) Combined with hepatocellular carcinoma or other malignant tumors; (2) Autoimmune cirrhosis, schistosomal cirrhosis, hepatic venous occlusion, etc.; (3) Combined with other diseases that affect portal hypertension, such as portal vein thrombosis; (4) Recently (within 6 months) received other treatments, such as TIPS, liver transplantation, or other treatment measures that may affect the study; (5) Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.);

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HVPG	After enrollment, HVPG testing was performed and appropriate endoscopic treatment was selected as a secondary prevention measure; HVPG testing was performed again approximately every 6-12 months.	Regular endoscopic treatment, with HVPG testing repeated approximately every 6-12 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices
• Other Study ID Numbers: 2024-0634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No