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

Sponsor
Asian Institute of Gastroenterology, India (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06114355
Collaborator
(none)
25
Enrollment
12
Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: EUS Portal pressure measurement

Study Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Comparison of Pre-operative EUS Guided and Intra-operative Direct Portal Vein Pressure Measurement in Pretransplant Cirrhotics - Prospective Observational Study
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM). [1 year]

    Correlation between EUS-PPM with direct intra-operative portal pressure measurement (IO-PPM).

Secondary Outcome Measures

  1. Correlation between readings of EUS-PPM using portable manometry set and arterial transducer. [1 year]

    Correlation between readings of EUS-PPM using portable manometry set and arterial transducer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohan Ramchandani, Consultant, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT06114355
Other Study ID Numbers:
  • PV01
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 2, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Liver Cirrhosis

Study Results

No Results Posted as of Nov 2, 2023