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EUS-PPG vs HVPG in Portal Hypertension (GRAPE)

Primary Purpose

Cirrhosis, Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
EUS-PPG and HVPG
Sponsored by
Hospital General Universitario de Alicante
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis focused on measuring EUS, Endoscopic ultrasound, Portal Hypertension, Portal pressure gradient, Hepatic venous pressure gradient

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unidad de Endoscopia. Hospital General Universitario de Alicante

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EUS-PPG and HVPG

Arm Description

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.

Outcomes

Primary Outcome Measures

Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.
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.

Secondary Outcome Measures

Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.
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.
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.
Proportion of adverse events in the EUS-PPG and HVPG using Chi-square.

Full Information

First Posted
December 1, 2021
Last Updated
September 20, 2023
Sponsor
Hospital General Universitario de Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT05689268
Brief Title
EUS-PPG vs HVPG in Portal Hypertension
Acronym
GRAPE
Official Title
EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
September 20, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General Universitario de Alicante

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Portal Hypertension
Keywords
EUS, Endoscopic ultrasound, Portal Hypertension, Portal pressure gradient, Hepatic venous pressure gradient

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-PPG and HVPG
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
EUS-PPG and HVPG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intra-class correlation coefficient between portal pressure gradient measurement by EUS and hepatic venous pressure gradient measurement measured by interventional radiology.
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients.
Description
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.
Time Frame
1 day
Title
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.
Description
Proportion of adverse events in the EUS-PPG and HVPG using Chi-square.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Unidad de Endoscopia. Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain

12. IPD Sharing Statement

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EUS-PPG vs HVPG in Portal Hypertension

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