Liver CirrhosisNCT03590288
Dynamic Monitor of Portacaval Pressure Gradient
An observational study of Liver Cirrhosis, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with PPG <12 mmHg are free from the risk of variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Transjugular intrahepatic portosystemic shunt
- Type of treatment
- Surgery or procedure
- How many people
- 567 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Aug 2023
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive cohort meeting the abovementioned criteria
Who may be able to join
- Patients with portal hypertensive complications
- Receiving TIPS due to variceal bleeding or refractory ascites
- Successful covered TIPS procedure
- Written informed consent
Who cannot join
- Lactating or pregnant
- Malignancies
- Uncontrolled infection (> grade 2)
- Severe cardiac, pulmonary or renal dysfunction
- Previously treated with TIPS
- Previous liver transplantation
- History of spontaneous overt HE or recurrent HE
Trial locations and contacts
1 site in 1 country.
China1 site
Xijing Hospital of Digestive Diseases, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Dynamic Monitor of Portacaval Pressure Gradient and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS
Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with PPG <12 mmHg are free from the risk of variceal bleeding. Transjugular intrahepatic portosystemic shunt (TIPS) markedly reduces PPG and is a very effective treatment for portal hypertension. A recent study showed that timing affects measurement of portacaval pressure gradient (PPG) after TIPS placement in patients with portal hypertension. The immediate PPG after TIPS placement cannot predict the long-term prognosis, while PPG measured with the patient on stable clinical conditions correlates with long term PPG and clinical outcomes. However, this finding remain to be validated. Previous studies have demonstrated that the achievement of a hepatic vein pressure gradient <12 mmHg eliminated the risk of recurrent variceal hemorrhage. Therefore, a post- TIPS PPG <12 mmHg was initially proposed as a hemodynamic target of TIPS, independent of the indication. It is important to note that most studies on hemodynamic targets were done before the introduction of covered stents and have not been adequately updated since then.Therefore, whether a post-TIPS PPG target <12 mmHg is the best cutoff for patients receiving a covered stent for the treatment of portal hypertension complications needs confirmation in well-designed studies.This study aims to dynamically monitor the change of PPG after TIPS procedure in patients with portal hypertension, and investigate its prognostic value in predicting patient outcome.
- Conditions
- Liver Cirrhosis
- Being tested
- Transjugular intrahepatic portosystemic shunt
- Keywords
- Liver cirrhosis, Transjugular intrahepatic portosystemic shunt, Pressure gradient, Outcome prediction
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular intrahepatic portosystemic shuntProcedure or surgery
Covered stents will be used, that will be dilated to 8 mm. The aim will be to reduce the portacaval pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed.
Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices.
After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.
Measurement of portacaval pressure gradient will be done immediate after TIPS, then repeated 1-3 days and at 1 month after the procedure.
A TIPS revision will be performed once shunt dysfunction is suspected.
| Study group | Role | What they receive |
|---|---|---|
| TIPS group | Pressure gradient were measured in consecutive cirrhotic patients undergoing TIPS. Receives: Procedure: Transjugular intrahepatic portosystemic shunt |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of portacaval pressure gradient
The portacaval pressure gradient is the difference between the portal vein and the inferior vena cava pressures during portal angiography
Measured: The change of PPG from immediately to 1 month after the procedure
Secondary outcomes (4)
Portal hypertension related complications
The incidence of portal hypertensionrelated bleeding or ascites
Measured: 3 years
Other portal hypertension complications
Spontaneous bacterial peritonitis, hepatorenal syndrome.
Measured: 3 years
Hepatic encephalopathy
Hepatic encephalopathy
Measured: 3 years
Survivial
Time from the procedure to the date of death.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 May 2018
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guohong Han, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590288
- Sponsor's protocol ID
- PRESSURE GRADIENT MONITOR
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2018
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lv Y, Wang Q, Luo B, Bai W, Li M, Li K, Wang Z, Xia D, Guo W, Li X, Yuan J, Zhang N, Wang X, Xie H, Pan Y, Nie Y, Yin Z, Fan D, Han G. Identifying the optimal measurement timing and hemodynamic targets of portal pressure gradient after TIPS in patients with cirrhosis and variceal bleeding. J Hepatol. 2025 Feb;82(2):245-257. doi: 10.1016/j.jhep.2024.08.007. Epub 2024 Aug 22.
PubMed 39181214
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitor of Portacaval Pressure Gradient and Its Prognostic Value in Predicting Outcomes in Patients Undergoing TIPS
- ClinicalTrials.gov ID
- NCT03590288
- Acronym / sponsor ID
- PRESSURE GRADIENT MONITOR
- Conditions
- Liver Cirrhosis
- Keywords
- Liver cirrhosis, Transjugular intrahepatic portosystemic shunt, Pressure gradient, Outcome prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 18 Jul 2018 (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.
Portacaval pressure gradient (PPG) plays an important role in prediction the outcomes of cirrhotic patients undergoing TIPS. An PPG over 20 mmHg indicates a high risk of failure to control bleeding or preventing rebleeding, while patients with PPG <12 mmHg are free from the risk of variceal bleeding. Transjugular intrahepatic portosystemic shunt (TIPS) markedly reduces PPG and is a very effective treatment for portal hypertension. A recent study showed that timing affects measurement of portacaval pressure gradient (PPG) after TIPS placement in patients with portal hypertension. The immediate PPG after TIPS placement cannot predict the long-term prognosis, while PPG measured with the patient on stable clinical conditions correlates with long term PPG and clinical outcomes. However, this finding remain to be validated. Previous studies have demonstrated that the achievement of a hepatic vein pressure gradient <12 mmHg eliminated the risk of recurrent variceal hemorrhage. Therefore, a post- TIPS PPG <12 mmHg was initially proposed as a hemodynamic target of TIPS, independent of the indication. It is important to note that most studies on hemodynamic targets were done before the introduction of covered stents and have not been adequately updated since then.Therefore, whether a post-TIPS PPG target <12 mmHg is the best cutoff for patients receiving a covered stent for the treatment of portal hypertension complications needs confirmation in well-designed studies.This study aims to dynamically monitor the change of PPG after TIPS procedure in patients with portal hypertension, and investigate its prognostic value in predicting patient outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIPS group | – | Procedure: Transjugular intrahepatic portosystemic shuntPressure gradient were measured in consecutive cirrhotic patients undergoing TIPS. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cohort meeting the abovementioned criteria
Key inclusion criteria (4 listed)
- Patients with portal hypertensive complications
- Receiving TIPS due to variceal bleeding or refractory ascites
- Successful covered TIPS procedure
- Written informed consent
Key exclusion criteria (7 listed)
- Lactating or pregnant
- Malignancies
- Uncontrolled infection (> grade 2)
- Severe cardiac, pulmonary or renal dysfunction
- Previously treated with TIPS
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 |
|---|---|---|
| Transjugular intrahepatic portosystemic shuntCovered stents will be used, that will be dilated to 8 mm. The aim will be to reduce the portacaval pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed. Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices. After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted. Measurement of portacaval pressure gradient will be done immediate after TIPS, then repeated 1-3 days and at 1 month after the procedure. A TIPS revision will be performed once shunt dysfunction is suspected. | Procedure or surgery | TIPS group |
Primary outcome
Change of portacaval pressure gradient
Time frame: The change of PPG from immediately to 1 month after the procedure
The portacaval pressure gradient is the difference between the portal vein and the inferior vena cava pressures during portal angiography
4 secondary outcomes
Portal hypertension related complications
Time frame: 3 years
Other portal hypertension complications
Time frame: 3 years
Hepatic encephalopathy
Time frame: 3 years
Survivial
Time frame: 3 years
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 12 Jan 2024.
- Derived from this study: PubMed 39181214Lv Y, Wang Q, Luo B, Bai W, Li M, Li K, Wang Z, Xia D, Guo W, Li X, Yuan J, Zhang N, Wang X, Xie H, Pan Y, Nie Y, Yin Z, Fan D, Han G. Identifying the optimal measurement timing and hemodynamic targets of portal pressure gradient after TIPS in patients with cirrhosis and variceal bleeding. J Hepatol. 2025 Feb;82(2):245-257. doi: 10.1016/j.jhep.2024.08.007. Epub 2024 Aug 22.
- Individual participant dataSharing planned: Undecided
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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 Liver Cirrhosis, run by Air Force Military Medical University, China 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 4 inclusion and 7 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 12 Jan 2024. 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?
Change of portacaval pressure gradient (time frame: The change of PPG from immediately to 1 month after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03590288, which also lists 1 linked publication.
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 12 Jan 2024.