Evaluation of Endoscopic Treatment Effect Based on HVPG

NCT06863519 | Enrolling By Invitation

• 1 other identifier: 2024-0634
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal and Gastric Varices

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Endoscopic treatment PROCEDURE

After the patient is enrolled, HVPG testing is performed, and appropriate endoscopic treatment is selected as a secondary prevention method. HVPG testing is performed again after regular endoscopic treatment.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients in gastroenterology department

You may qualify if:

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

You may not qualify if:

• (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.);

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 7, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)