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

NCT07478770 | Completed

• 1 other identifier: 2025-0822
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal and Gastric Varices

Outcome Measures

Primary Outcomes (3)

• HVPG

  From enrollment to the end of treatment at 4 weeks

• EUS-PPG

  From enrollment to the end of treatment at 4 weeks

• GVPG

  From enrollment to the end of treatment at 4 weeks

Eligibility Criteria

• Age: 18 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:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, 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: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 17, 2026
• Study Start: July 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)