Liver CirrhosisNCT06114355
Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics
An observational study of Liver Cirrhosis, run by Asian Institute of Gastroenterology, India.
Trial summary
Direct portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation… 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?
- EUS Portal pressure measurement
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Dec 2024
- 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: Decompensated Cirrhosis patient listed for liver transplant according to the standard indications.
Who may be able to join
- Liver cirrhosis patients scheduled for liver transplant for the standard indications within next 24- 48 hours will be included.
Who cannot join
- Severe ascites not amenable for tapping
- History of blood thinner consumption within last 5 days
- Active duodenal ulcerations
About this study
Official title: Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics - Prospective Observational Study
Direct portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation (PIM). This pilot study aims to assess correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
- Conditions
- Liver Cirrhosis
- Being tested
- EUS Portal pressure measurement
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS Portal pressure measurementProcedure or surgery
Direct portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation (PIM)
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
Measured: 1 year
Secondary outcomes (1)
Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.
Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.
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 posted2 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Asian Institute of Gastroenterology, IndiaThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114355
- Sponsor's protocol ID
- PV01
- Status last verified
- Oct 2023
- First submitted
- 28 Oct 2023
- Last updated
- 2 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics - Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06114355
- Acronym / sponsor ID
- PV01
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 2 Nov 2023 (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.
Direct portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation (PIM). This pilot study aims to assess correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Decompensated Cirrhosis patient listed for liver transplant according to the standard indications.
Key inclusion criteria (1 listed)
- Liver cirrhosis patients scheduled for liver transplant for the standard indications within next 24- 48 hours will be included.
Key exclusion criteria (3 listed)
- Severe ascites not amenable for tapping
- History of blood thinner consumption within last 5 days
- Active duodenal ulcerations
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 Portal pressure measurementDirect portal pressure measurement under EUS-guidance (EUS-PPM) is a promising alternative to conventional indirect Hepatic Venous Pressure Gradient (HVPG). In patients undergoing liver transplantation for cirrhosis, high pre-operative portal vein (PV) pressure requires intra-operative portal vein inflow modulation (PIM) | Procedure or surgery | – |
Primary outcome
Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
Time frame: 1 year
Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).
1 secondary outcome
Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Asian Institute of Gastroenterology, India.
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 3 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM). (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 2 Nov 2023.