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Enrolling by Invitation

NCT Number: NCT06863519

Evaluation of Endoscopic Treatment Effect 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.);

Treatment and study plan

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.

Primary outcomes

  1. HVPG

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

    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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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