Study on Portal Vein Pressure Gradient Measurement Under Endoscopic Ultrasound Guidance for Gastr… (NCT07478770) | Clinical Trial Compass
CompletedNot Applicable
Study on Portal Vein Pressure Gradient Measurement Under Endoscopic Ultrasound Guidance for Gastric Fundal Varices
China25 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
HVPG
Timeframe: From enrollment to the end of treatment at 4 weeks
2
EUS-PPG
Timeframe: From enrollment to the end of treatment at 4 weeks
3
GVPG
Timeframe: From enrollment to the end of treatment at 4 weeks
Trial details
NCT IDNCT07478770
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University