EUS-PPG vs HVPG in Portal Hypertension

NCT05689268 | Completed

• 1 other identifier: PI2021-135
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Portal Hypertension

Keywords

EUS; Endoscopic ultrasound; Portal Hypertension; Portal pressure gradient; Hepatic venous pressure gradient

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (2)

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

  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.

  30 days

Study Arms (1)

EUS-PPG and HVPG

OTHER

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

Interventions

EUS-PPG and HVPG DIAGNOSTIC_TEST

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.

EUS-PPG and HVPG

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

Study Sites (1)

Unidad de Endoscopia. Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy Unit

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 19, 2023
• Study Start: February 1, 2023
• Primary Completion: September 20, 2023
• Study Completion: September 20, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

ES (1)