EUS Elastography for Predicting Cirrhotic-related Complications
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04155398|
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
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
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|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|
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.
- 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
- 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
- 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)
- 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
- Adverse events related to procedure [ Time Frame: peri-procedure ]Adverse events related to procedure
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
|Contact: Thomas Lam, BSemail@example.com|
|Prince of Wales Hospital, The Chinese University of Hong Kong||Recruiting|
|Sha Tin, New Territories, Hong Kong|
|Contact: Thomas Lam, BS 852-3505-3509 firstname.lastname@example.org|
|Principal Investigator: Raymond S Tang, MD|
|Principal Investigator:||Raymond Tang, MD||Chinese University of Hong Kong|