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

NCT ID: NCT03989973

Last Updated: 2019-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2023-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Liver Cirrhosis Esophageal Varices Liver Stiffness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cirrhosis patients

Patients were diagnosed by liver biopsy, CT or ultrasound

Gastroscopy

Intervention Type DIAGNOSTIC_TEST

Gastroscopy

Interventions

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Gastroscopy

Gastroscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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luo xuefeng

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuefeng Luo

Role: PRINCIPAL_INVESTIGATOR

West China Hospital of Sicuan Univerisity

Locations

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West China Hospital of Sichuan Univerisity

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuling Yan, Phd

Role: CONTACT

+86 13648056747

Facility Contacts

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Yuling Yan, PhD

Role: primary

+86 13648056747

Other Identifiers

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2D-SWE evaluate varices

Identifier Type: -

Identifier Source: org_study_id

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