Esophageal and Gastric VaricesNCT07478770
Study on Portal Vein Pressure Gradient Measurement Under Endoscopic Ultrasound Guidance for Gastric Fundal Varices
An observational study of Esophageal and Gastric Varices, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal and Gastric Varices
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients in gastroenterology department
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
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
- Medical subject headings
- Esophageal and Gastric Varices
What is being measured
The primary outcome is the main question the study is designed to answer.
HVPG
Measured: From enrollment to the end of treatment at 4 weeks
EUS-PPG
Measured: From enrollment to the end of treatment at 4 weeks
GVPG
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jul 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal and Gastric VaricesStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478770
- Sponsor's protocol ID
- 2025-0822
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Portal Vein Pressure Gradient Measurement Under Endoscopic Ultrasound Guidance for Gastric Fundal Varices
- ClinicalTrials.gov ID
- NCT07478770
- Acronym / sponsor ID
- 2025-0822
- Conditions
- Esophageal and Gastric Varices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients in gastroenterology department
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal and Gastric Varices, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HVPG (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.