NCT06114355

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 2, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 28, 2023

Last Update Submit

November 1, 2023

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    1 year

Interventions

EUS Portal pressure measurementPROCEDURE

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)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Decompensated Cirrhosis patient listed for liver transplant according to the standard indications.

You may qualify if:

  • Liver cirrhosis patients scheduled for liver transplant for the standard indications within next 24- 48 hours will be included.

You may not qualify if:

  • Severe ascites not amenable for tapping
  • History of blood thinner consumption within last 5 days
  • Active duodenal ulcerations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 28, 2023

First Posted

November 2, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 2, 2023

Record last verified: 2023-10