EUS Elastography for Predicting Cirrhotic-related Complications

NCT04155398 | Active Not Recruiting

• 1 other identifier: EUS-E study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the tissue stiffness as a surrogate marker of degree of liver cirrhosis has gained popularity in recent decades. Current guidelines also advocate the use of Fibroscan® machine (EchoSens, Paris, France) to detect any advanced liver fibrosis as represented by high liver stiffness, for prediction of varices development. Apart from liver stiffness, studies have shown that spleen stiffness (SS) has been proven another useful parameter to severity of underlying portal hypertension and liver cirrhosis. However, spleen stiffness measurement by Fibroscan® is highly limited by the thickness of subcutaneous soft tissue or abdominal wall tissue, especially in obese subjects. It carries certain technical difficulty as well due to its deep-seated anatomical position. Recently, the technique of endoscopic ultrasound elastography (EUS-E) has been described. It can overcome the limitations of Fibroscan by making measurements of liver and spleen stiffness through the gastric wall, which has a shorter distance than the abdominal wall. It also allows concomitant upper GI tract luminal examination, incorporating both esophagogastroduodenoscopy and elastography measurements into one procedure at the same time. This research study aims to prospectively study the utility of EUS-E in patients with chronic liver diseases, both in terms of diagnostic and prognostic indications for future cirrhotic-related complications.

Conditions

Liver Fibroses

Keywords

liver stiffness; EUS elastography

Outcome Measures

Primary Outcomes (2)

• Inter-observer and intra-observer variability of liver and spleen stiffness measurements by EUS-E among endoscopists with different EUS experience

  Inter-observer and intra-observer variability of liver and spleen stiffness measurements by EUS-E among endoscopists with different EUS experience

  peri-procedure

• Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict variceal development and/or bleeding

  Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict variceal development and/or bleeding

  Follow up for 2 years after index study endoscopy

Secondary Outcomes (3)

• Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict other liver cirrhosis complications (eg, ascites, hepatic encelopathy, etc)

  Follow up for 2 years after index study endoscopy

• Correlation of liver fibrosis by EUS-E to Fibroscan

  Follow up for 2 years after index study endoscopy

• Adverse events related to procedure

  peri-procedure

Study Arms (1)

Study group

Patients with radiologic features suggestive of cirrhosis on abdominal imaging studies such as transabdominal ultrasound, CT or MRI and indication for variceal screening, suspected advanced liver fibrosis as detected by Fibroscan, or with clinical evidence of hypersplenism would be invited for the study

Procedure: EUS elastography

Interventions

EUS elastography PROCEDURE

A forward view radial echoendoscope or a forward oblique view linear echoendoscope would be used to perform focused luminal examination of varices and EUS elastography for measurement of liver stiffness and spleen stiffness.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with radiologic features suggestive of cirrhosis on abdominal imaging studies such as transabdominal ultrasound, CT or MRI and indication for variceal screening, suspected advanced liver fibrosis as detected by Fibroscan, or with clinical evidence of hypersplenism would be invited for the study

You may qualify if:

• Patients with radiologic features suggestive of cirrhosis on abdominal imaging studies such as transabdominal ultrasound, CT or MRI and indication for variceal screening
• Patients with suspected advanced liver fibrosis as detected by Fibroscan
• Patients with clinical evidence of hypersplenism
• Age \> 18 years
• Written informed consent available

You may not qualify if:

• Patients with features of decompensated cirrhosis, such as history of ascites, prior variceal bleeding, hepatic encephalopathy, hepatorenal syndrome
• Patients with history of hepatocellular carcinoma
• Patients with history of liver transplant or TIPS or shunting surgery
• Patients with portal and/or mesenteric vein thrombosis
• Moribund patients from terminal illnesses
• Patients with terminal malignancy
• Contraindications for endoscopy
• Unable to provide written informed consent
• Pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Raymond Tang, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Study Record Dates

• First Submitted: November 3, 2019
• First Posted: November 7, 2019
• Study Start: November 4, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)