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Enrolling by invitation NCT06863519

Evaluation of Endoscopic Treatment Effect Based on HVPG

— Observational Esophageal and Gastric Varices

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic treatment.
Who it may be relevant to
Registry conditions: Esophageal and Gastric Varices. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Procedure Endoscopic treatment
    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.

Primary outcome measures

  • HVPG [Time frame: Regular endoscopic treatment, with HVPG testing repeated approximately every 6-12 months]

Eligibility criteria

Inclusion criteria

  • 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;

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.);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT06863519 · 2024-0634

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗