Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics
November 1, 2023 updated by: Mohan Ramchandani, Asian Institute of Gastroenterology, India
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
25
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Decompensated Cirrhosis patient listed for liver transplant according to the standard indications.
Description
Inclusion Criteria:
- Liver cirrhosis patients scheduled for liver transplant for the standard indications within next 24- 48 hours will be included.
Exclusion Criteria:
- Severe ascites not amenable for tapping
- History of blood thinner consumption within last 5 days
- Active duodenal ulcerations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.
Time Frame: 1 year
|
Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 1, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 28, 2023
First Submitted That Met QC Criteria
November 1, 2023
First Posted (Actual)
November 2, 2023
Study Record Updates
Last Update Posted (Actual)
November 2, 2023
Last Update Submitted That Met QC Criteria
November 1, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.