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NCT06114355 Clinical Trial

Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics

Liver Cirrhosis Clinical Trial

Official title:
Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics - Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06114355
Other study ID # PV01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 1, 2024

Study information
Verified date October 2023
Source Asian Institute of Gastroenterology, India
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 (PIM). This pilot study aims to assess correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 25
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• EUS Portal pressure measurement
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)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Asian Institute of Gastroenterology, India

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 1 year
Secondary 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. 1 year
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