Cirrhosis PortalNCT05597488
EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
A study testing EUS guided portal pressure gradient measurement in people with Cirrhosis Portal, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis Portal
- What is being tested?
- EUS guided portal pressure gradient measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 to 75 years old
- Informed consent available
- Suffering from chronic hepatitis induced cirrhosis
- Suffering from oesophageal varices and received EVL as a result of
- Primary variceal prophylaxis during a variceal surveillance program on oesophagogastroduodenoscopy (OGD) or
- Secondary variceal prophylaxis after EVL in patients with active oesophageal variceal bleeding
- Or bleeding gastric varices that have received endoscopic canoacrylate injection
Who cannot join
- Medical Child-Pugh Class C Uncorrected platelet count <50,000 INR > 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
- Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).
- Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation
- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.
- Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese University of Hong Kong
Hong Kong, Hong Kong
Anthony Y Teoh, FRCSEd(Gen), 35052956, anthonyteoh@surgery.cuhk.edu.hk
Anthony Y Teoh, FRCSEd(Gen)
About this study
The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.
- Conditions
- Cirrhosis Portal
- Being tested
- EUS guided portal pressure gradient measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS guided portal pressure gradient measurementDevice
EUS-guided PPGM is performed under monitored anaesthesia. The linear array echoendoscope is passed from the mouth into the stomach and duodenum, as with a standard exam. Under endoscopic ultrasound guidance, a 25 gauge EUS needle (Echotip, Cook Medical, USA) primed with heparin 100 USP/ml is then placed across the stomach or duodenal wall and through the liver parenchyma into the portal vein (Figure 3). A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle (Figure 4). Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The needle is then removed from the portal vein and liver, if necessary. The process is repeated for the hepatic vein (Figure 5). The EUS - PPG is calculated by subtracting the average of the three hepatic vein pressure measurements from the average of the 3 direct portal vein pressure measurements.
| Study group | Role | What they receive |
|---|---|---|
| EUS guided portal pressure gradient measurement | Experimental | At index OGD, the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. After endoscopic treatment of varices, recruited patients would undergo 1st measurement of EUS-PPG within 10-14 days after index OGD. The patients would then be enrolled into a variceal surveillance program and be started on B-blockers if not already prescribed. The patients would then be scheduled for another follow-up OGD at 3 months with measurement of the 2nd EUS-PPG. Finally, a third follow-up OGD and EUS-PPG would be performed in 1-year after 1st EUS-PPG. Endoscopic findings attributed to chronic cirrhosis would be assessed in the 3 months and 1 year OGD and the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. Receives: Device: EUS guided portal pressure gradient measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.
Measured: 1 year
Secondary outcomes (1)
Other outcome measurements
The value of Day 0, 3 months or 1year EUS-PPG would be correlated with the severity of cirrhosis, re-bleeding, number of sessions of repeated EVL and mortality at 1 year. Safety of the procedure would also be assessed as 30-day adverse events.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Nov 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis PortalStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Teoh, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597488
- Sponsor's protocol ID
- 2022.088
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2022
- Last updated
- 20 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 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS Guided Portal-systemic Pressure Gradient Measurement to Predict Treatment Response and Outcomes of Varices to Endoscopic Variceal Ligation in Patients With Chronic Hepatitis.
- ClinicalTrials.gov ID
- NCT05597488
- Acronym / sponsor ID
- 2022.088
- Conditions
- Cirrhosis Portal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 28 Oct 2022 (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.
The aim of the current study is to assess if EUS-PPGM could predict the treatment response and outcomes of varices to endoscopic variceal ligation (EVL) in patients with chronic hepatitis. The hypothesis is that a high EUS-PPGM value at 3 months correlates with the presence of varices requiring EVL in patients that have received primary or secondary variceal prophylaxis on 1 year follow-up upper endoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS guided portal pressure gradient measurement | Experimental | Device: EUS guided portal pressure gradient measurementAt index OGD, the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. After endoscopic treatment of varices, recruited patients would undergo 1st measurement of EUS-PPG within 10-14 days after index OGD. The patients would then be enrolled into a variceal surveillance program and be started on B-blockers if not already prescribed. The patients would then be scheduled for another follow-up OGD at 3 months with measurement of the 2nd EUS-PPG. Finally, a third follow-up OGD and EUS-PPG would be performed in 1-year after 1st EUS-PPG. Endoscopic findings attributed to chronic cirrhosis would be assessed in the 3 months and 1 year OGD and the presence and severity of OV, GV and portal hypertensive gastropathy would be recorded. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 to 75 years old
- Informed consent available
- Suffering from chronic hepatitis induced cirrhosis
- Suffering from oesophageal varices and received EVL as a result of
- Or bleeding gastric varices that have received endoscopic canoacrylate injection
Key exclusion criteria (5 listed)
- Medical Child-Pugh Class C Uncorrected platelet count <50,000 INR > 1.5 (natural) History of hepatic encephalopathy Current or history of hepatocellular carcinoma
- Anatomical Main portal vein thrombosis Anatomic alterations of the hepatic vasculature that prevent access to the portal vein or intrahepatic portion of the hepatic veins (identified at screening and/or during the endoscopic procedure).
- Previous history of spontaneous bacterial peritonitis within the previous three months Portopulmonary hypertension Cardiac decompensation
- Endoscopically Confirmed Exclusion Criteria Presence of ascites in the path of the needle that prevents apposition of the gastrointestinal tract and liver.
- Presence of gastric or duodenal ulcers, dieulafoy's lesion or cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS guided portal pressure gradient measurementEUS-guided PPGM is performed under monitored anaesthesia. The linear array echoendoscope is passed from the mouth into the stomach and duodenum, as with a standard exam. Under endoscopic ultrasound guidance, a 25 gauge EUS needle (Echotip, Cook Medical, USA) primed with heparin 100 USP/ml is then placed across the stomach or duodenal wall and through the liver parenchyma into the portal vein (Figure 3). A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle (Figure 4). Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The needle is then removed from the portal vein and liver, if necessary. The process is repeated for the hepatic vein (Figure 5). The EUS - PPG is calculated by subtracting the average of the three hepatic vein pressure measurements from the average of the 3 direct portal vein pressure measurements. | Device | EUS guided portal pressure gradient measurement |
Primary outcome
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy
Time frame: 1 year
The number of patients with a high EUS-PPGM at 3 months will be correlated with the presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy.
1 secondary outcome
Other outcome measurements
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS guided portal pressure gradient measurement in people with Cirrhosis Portal, run by Chinese University of Hong Kong 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony Teoh (852-35052956, anthonyteoh@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of varices requiring EVL on 1 year follow-up upper endoscopy (time frame: 1 year). 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 20 Mar 2026.