EUS-PPG vs HVPG in Portal Hypertension (GRAPE)

September 20, 2023 updated by: Jose Ramon Aparicio Tormo, Hospital General Universitario de Alicante

EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)

The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Unidad de Endoscopia. Hospital General Universitario de Alicante

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

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age above 18 years
  • Undergoing evaluation for chronic liver disease or portal hypertension
  • Signed informed consent

Exclusion Criteria:

  • Uncorrectable coagulopathy (INR above 1.5)
  • Uncorrectable thrombocytopenia (Platelets under 50,000)
  • Anticoagulation or antiplatelet therapy that cannot be discontinued
  • Biliary obstruction
  • Grade II ascites or more
  • Intrahepatic portal vein thrombosis
  • Pregnancy

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EUS-PPG and HVPG

EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained.

On the same day or on successive days HVPG measurement will be performed.
Diagnostic test: EUS-PPG and HVPG

EUS-PPG and HVPG will be measured in all patients. Under deep sedation with propofol, an echoendoscopy will be performed. After identifying the left or middle suprahepatic vein, it will be punctured with a standard 22 G needle. The needle will be previously purged with heparinized saline and connected to a venous pressure monitor via an arterial pressure system, which will be calibrated to zero at the level of the axillary midline, at the level of the atrium. Subsequently, the left portal vein will be identified from the stomach or duodenum, repeating the procedure. From each vessel 3 measurements will be taken by flushing 1-2 ml of heparinized saline. The mean of the three measurements will be obtained.

On the same day or on successive days HVPG measurement will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.
Time Frame: 1 day
Portal pressure gradient measurement will be performed by direct echoendoscopy-guided puncture with a 22 G needle of the portal vein and the suprahepatic vein. On the same day or on successive days, hepatic venous pressure gradient determination will be performed by interventional radiology. For this purpose, the free hepatic venous pressure and the wedged pressure will be measured using a balloon catheter and jugular approach, following the usual procedure.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.
Time Frame: 1 day
The percentage of echoendoscopy-guided portal pressure gradient (EUS-PPG) measurements versus the percentage of successful hepatic venous pressure gradient (HVPG) measurements using Chi-square will be compared.
1 day
Adverse effects at 30 days after each procedure by clinical follow-up of patients at 24 hours, 7 days, and 30 days using the American Society of Gastrointestinal Endoscopy Severity grading system, from mild to fatal.
Time Frame: 30 days
Proportion of adverse events in the EUS-PPG and HVPG using Chi-square.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario de Alicante

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 (Actual)

February 1, 2023

Primary Completion (Actual)

September 20, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 19, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2021-135

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.

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