Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis

June 17, 2019 updated by: luo xuefeng, West China Hospital

West China Hospital, Sichuan University

The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Variceal bleeding is a fatal complication in patients with liver cirrhosis. A screening esophagogastroduodenoscopy (EGD) is recommended in all patients with cirrhosis to identify those patients at risk of variceal bleeding. However, this technique is invasive, uncomfortable and costly. Moreover, with the development of noninvasive technology for early diagnosis of liver cirrhosis, half of these patients will not develop varices within 10 years and therefore will undergo unnecessary EGD screening. Thus, the need for noninvasive screening methods for varices in patients with cirrhosis is urgent.

2D-SWE is a promising new type of shear wave-based ultrasound technique for measuring LS. The shear waves are generated directly within the tissue by acoustic radiation force impulse, allowing the measurement of stiffness in patients with ascites. In addition, the LS values can be obtained on the basis of anatomic information to avoid major vessels and control major measurement bias. 2D-SWE has been reported to have high reliability and reproducibility in assessing liver stiffness. Several studies compared TE with 2D-SWE in predicting fibrosis stages and portal hypertension, which suggested that 2D-SWE has a higher technical success rate and a better diagnostic value for portal hypertension than TE.The purpose of this retrospective study was to investigate the diagnostic performance of 2D-SWE for predicting the presence of esophageal varices and high-risk varices in patients with liver cirrhosis.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan Univerisity
        • Contact:
          • Yuling Yan, PhD
          • Phone Number: +86 13648056747

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

compensated cirrhosis

Description

Inclusion Criteria:

  • Cirrhosis were diagnosed by liver biopsy, CT and ultrasound before enrolled
  • Age was 16-80

Exclusion Criteria:

  • With bleeding history
  • With EVL history, BRTO or TIPS history
  • With NSBB history
  • With ascites
  • With splenectomy or splenic embolism, history
  • With liver cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cirrhosis patients
Patients were diagnosed by liver biopsy, CT or ultrasound
Diagnostic test: Gastroscopy
Gastroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Liver Stiffness
Time Frame: 1 day (At 2D-SWE scanning time)
Liver stiffness assessed by 2D-SWE
1 day (At 2D-SWE scanning time)
Varices stage
Time Frame: 1 day (At gastroscopy performed time)
Gastroscopy was used to assess varices stage
1 day (At gastroscopy performed time)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Xuefeng Luo, West China Hospital of Sicuan Univerisity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ANTICIPATED)

September 1, 2022

Study Completion (ANTICIPATED)

September 1, 2023

Study Registration Dates

First Submitted

June 16, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (ACTUAL)

June 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2D-SWE evaluate varices

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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