Study on Portal Vein Pressure Gradient Measurement Under Endoscopic Ultrasound Guidance for Gastric Fundal Varices

This study aimed to evaluate the feasibility and safety of direct gastric variceal pressure measurement in patients with large spontaneous portosystemic shunts, and to determine whether the gastric variceal pressure gradient (GVPG)-defined as directly measured gastric variceal pressure (GVP) minus hepatic vein pressure (HVP)-offers superior predictive value for bleeding risk compared to conventional HVPG and EUS-PPG in this challenging patient population.

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Key information

Conditions

Esophageal and Gastric Varices Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Hypertension, Portal Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) age≥18 years; (2) hospitalized patients with a confirmed diagnosis of cirrhosis with gastric varices and large spontaneous shunts based on clinical, laboratory, and imaging findings; and (3) provided written informed consent for all diagnostic and therapeutic procedures.

Exclusion criteria

(1) significant coagulopathy, defined as an international normalized ratio (INR) > 1.5; (2) severe thrombocytopenia (platelet counts < 20×10^9/L); (3) presence of severe systemic comorbidities, such as active sepsis, decompensated heart failure, or severe chronic obstructive pulmonary disease; (4) psychiatric disorders precluding procedure cooperation; (5) concurrent malignant tumors; or (6) refusal to undergo hepatic venous pressure gradient (HVPG) or endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement.

Treatment and study plan

Primary outcomes

HVPG

Time frame: From enrollment to the end of treatment at 4 weeks
EUS-PPG

Time frame: From enrollment to the end of treatment at 4 weeks
GVPG

Time frame: From enrollment to the end of treatment at 4 weeks

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Mar 17, 2026
Registry last updated: Mar 17, 2026

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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Completed