Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements

NCT06216509 | Completed

• 1 other identifier: 187214022023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Portal hypertension (PHT) is the main consequence of advanced chronic liver diseases (ACLD) and is often associated with severe complications leading to increased morbidity and mortality. Currently, the gold standard for the evaluation of the severity of PHT is the hepatic venous-pressure gradient (HVPG). The disadvantage of using the HVPG, besides the availability of the technique only in referral centres, is in the case of patients with vascular liver disorders because the HVPG underestimates the severity of PHT. Recent studies have evaluated the feasibility of the pressure gradient measurement through endoscopic transgastric and transhepatic access using special kit with a 25-gauge FNA needle (Cook Medical, Winston-Salem, NC, USA) and a compact manometer (Cook Medical, Bloomington, Ind, USA) that has the disadvantage of high purchase cost, no tracing of pressure possible and has not yet been properly correlated with the gold standard HVPG measurement or PPG measurement thus limiting its use in current practice. The aim of the study is 1. to assess and compare the correlations in the porto-systemic gradient measurement between a) direct portal vein puncture during TIPS insertion, b) direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound procedure and c) indirect portal vein pressure measurements using the interventional radiology based hepatic HVPG procedure in patients with cirrhosis submitted to TIPS procedure for complications of portal hypertension and 2. To evaluate and compare the porto-systemic gradient obtained by direct portal and hepatic pressure measurements using a 22 Gauge FNA needle during endoscopic ultrasound and indirect measurement through HVPG measuring in patients with presinusoidal hypertension and those with portal vein thrombosis.

Conditions

Cirrhosis; Vascular Diseases

Keywords

portal pressure gradient; endoscopic ultrasound; HVPG; portal hypertension

Outcome Measures

Primary Outcomes (3)

• Correlation of the porto systemic pressure gradient measured by EUS and TIPS

  in the first 12 months, patients enrolled will perform EUS and TIPS placement; measurement will be done according to protocol

  1 year

• Correlation of the hepatic venous pressure gradient and portosystemic pressure gradient

  in the first 12 month, patients enrolled will perform EUS and TIPS placement; measurement will be done according to protocol

  1 year

• Correlation of the porto systemic pressure gradient and portal hypertension signs

  in the next 12 months, patients meeting criteria will perform EUS pressure assessment and detection of varices

  1 year

Study Arms (2)

cirrhosis

OTHER

patients with cirrhosis undergoing TIPS placement

Device: Endoscopic ultrasound pressure measurement

porto sinusoidal vascular disorder and portal vein thrombosis

OTHER

patients with porto sinusoidal vascular disorder and portal vein thrombosis either in the context of cirrhosis or non cirrhotic portal vein thrombosis

Device: Endoscopic ultrasound pressure measurement

Interventions

Endoscopic ultrasound pressure measurement DEVICE

all eligible patients from both groups will undergo Endoscopic ultrasound pressure measurement under sedation.

cirrhosis; porto sinusoidal vascular disorder and portal vein thrombosis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with cirrhosis undergoing TIPS placement and patients with presinusoidal portal hypertension and patients with portal vein thrombosis

You may not qualify if:

• Patient is \< 18 or \> 85 years of age
• Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
• Patient is unwilling or unable to sign and date the informed consent
• Patient for whom endoscopic procedures are contraindicated
• Patients for whom propofol general anesthesia is contraindicated
• Previous transjugular intrahepatic or surgical portosystemic shunt
• Previous total or partial splenectomy
• Known history of spontaneous bacterial peritonitis (SBP) within the last three months irrespective of treatment for SBP
• Patients with known infection which is not controlled by medical intervention
• Severe Portopulmonary hypertension contraindicating TIPS placement
• Cardiac decompensation
• Cholestatic liver disease
• Patients with current advanced hepatocellular carcinoma (HCC)
• Emergent salvage TIPS placement in patients with failure to control bleeding
• Severe coagulopathy

Sponsors & Collaborators

• Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor: lead
• Iuliu Hatieganu University of Medicine and Pharmacy: collaborator

Study Sites (1)

Regional Institute of Gastroenterology and Hepatology Prof. Dr. O. Fodor

Cluj-Napoca, Cluj, 400158, Romania

Location

Related Publications (2)

• Samarasena JB, Huang JY, Tsujino T, Thieu D, Yu A, Hu KQ, Lee J, Chang KJ. EUS-guided portal pressure gradient measurement with a simple novel device: a human pilot study. VideoGIE. 2018 Oct 25;3(11):361-363. doi: 10.1016/j.vgie.2018.07.013. eCollection 2018 Nov.

  PMID: 30402586 BACKGROUND

• Huang JY, Samarasena JB, Tsujino T, Chang KJ. EUS-guided portal pressure gradient measurement with a novel 25-gauge needle device versus standard transjugular approach: a comparison animal study. Gastrointest Endosc. 2016 Aug;84(2):358-62. doi: 10.1016/j.gie.2016.02.032. Epub 2016 Mar 3.

  PMID: 26945557 BACKGROUND

MeSH Terms

Conditions

Fibrosis; Vascular Diseases; Hypertension, Portal

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrada Seicean, Prof MD PhD

  Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

  PRINCIPAL INVESTIGATOR

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: Clinical Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: January 22, 2024
• Study Start: January 10, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

RO (1)