Clincosm LogoSign in Get a demo

GRAPE: EUS-PPG vs HVPG in Portal Hypertension

Sponsor
Hospital General Universitario de Alicante (Other)
Overall Status
Recruiting
CT.gov ID
NCT05689268
Collaborator
(none)
53
Enrollment
1
Location
1
Arm
2.9
Anticipated Duration (Months)
18.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: EUS-PPG and HVPG
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
EUS-portal Pressure Gradient (EUS-PPG). Prospective Study Compared With Hepatic Venous Pressure Gradient (HVPG)
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Technical success of both procedures measured as the number of procedures successfully performed divided by the total number of patients. [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.

  2. 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. [30 days]

    Proportion of adverse events in the EUS-PPG and HVPG using Chi-square.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Unidad de Endoscopia. Hospital General Universitario de Alicante Alicante Spain 03010

Sponsors and Collaborators

  • Hospital General Universitario de Alicante

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jose Ramon Aparicio Tormo, Head of Endoscopy Unit, Hospital General Universitario de Alicante
ClinicalTrials.gov Identifier:
NCT05689268
Other Study ID Numbers:
  • PI2021-135
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jose Ramon Aparicio Tormo, Head of Endoscopy Unit, Hospital General Universitario de Alicante
EUS
Endoscopic ultrasound
Portal Hypertension
Portal pressure gradient
Hepatic venous pressure gradient
Additional relevant MeSH terms:
Hypertension, Portal
Hypertension

Study Results

No Results Posted as of Jan 19, 2023