NCT05789641

Brief Summary

According to international guidelines, Hepatic Venous Pressure Gradient is the gold standard technique for portal hypertension measurement, but it is invasive and poorly available. Currently, surveillance of oesophageal/gastric varices is performed by upper gastrointestinal endoscopy. More recently, non-invasive tools to estimate portal hypertension have been developed and, among them, ultrasound elastography has been proposed as a technique to stratify patient risk to have portal hypertension. Aim of this study is to evaluate the relationship between ultrasound evaluation (D-CEUS + elastography) and endoscopic parameters predictive of clinically significant portal hypertension in patients with liver cirrhosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

3.7 years

First QC Date

March 16, 2023

Last Update Submit

August 2, 2023

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

  • to evaluate the relationship between ultrasound and endoscopic parameters which predict clinically significant portal hypertension

    3 months after endoscopic exam

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult cirrhotic patients

You may qualify if:

  • written informed consent
  • age more than 18 years
  • diagnosis of cirrhosis of different etiologies

You may not qualify if:

  • previous recent endoscopic treatment of oesophageal varices (\<6 months)
  • portal and/or splanchnic thrombosis
  • portal cavernomatosis
  • acute or chronic heart failure
  • previous liver transplantation
  • presence of hepatocellular carcinoma or other hepatic neoplasms
  • inadequate visualization of the liver parenchyma on B-mode ultrasound
  • known allergy to ultrasound contrast medium
  • pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Central Study Contacts

Maria Assunta Zocco

CONTACT

00393470597805mariaassunta.zocco@policlinicogemelli.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 16, 2023

First Posted

March 29, 2023

Study Start

March 23, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

August 3, 2023

Record last verified: 2023-08

Locations

IT(1)