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EUS Elastography for Predicting Cirrhotic-related Complications

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ClinicalTrials.gov Identifier: NCT04155398
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond Shing Yan Tang, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment
Liver Fibroses Procedure: EUS elastography

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study on the Utility of Endoscopic Ultrasound Elastography (EUS-E) for Predicting Cirrhotic-related Complications in Patients With Chronic Liver Diseases
Actual Study Start Date : November 4, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Inter-observer and intra-observer variability of liver and spleen stiffness measurements by EUS-E among endoscopists with different EUS experience [ Time Frame: peri-procedure ]
    Inter-observer and intra-observer variability of liver and spleen stiffness measurements by EUS-E among endoscopists with different EUS experience

  2. Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict variceal development and/or bleeding [ Time Frame: Follow up for 2 years after index study endoscopy ]
    Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict variceal development and/or bleeding


Secondary Outcome Measures :
  1. Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict other liver cirrhosis complications (eg, ascites, hepatic encelopathy, etc) [ Time Frame: Follow up for 2 years after index study endoscopy ]
    Diagnostic performance of liver and spleen stiffness measurements by EUS-E to predict other liver cirrhosis complications (eg, ascites, hepatic encelopathy, etc)

  2. Correlation of liver fibrosis by EUS-E to Fibroscan [ Time Frame: Follow up for 2 years after index study endoscopy ]
    Correlation of liver fibrosis by EUS-E to Fibroscan

  3. Adverse events related to procedure [ Time Frame: peri-procedure ]
    Adverse events related to procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155398


Contacts
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Contact: Thomas Lam, BS 852-3505-3509 thomaslam@cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Sha Tin, New Territories, Hong Kong
Contact: Thomas Lam, BS    852-3505-3509    thomaslam@cuhk.edu.hk   
Principal Investigator: Raymond S Tang, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Raymond Tang, MD Chinese University of Hong Kong

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Responsible Party: Raymond Shing Yan Tang, Clinical Professional Consultant, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04155398     History of Changes
Other Study ID Numbers: EUS-E study
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raymond Shing Yan Tang, Chinese University of Hong Kong:
liver stiffness
EUS elastography
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases