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

Liver Cirrhosis Clinical Trial

Official title:

West China Hospital, Sichuan University

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03989973
• Other study ID #: 2D-SWE evaluate varices
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2019
• Source: West China Hospital
• Contact: Yuling Yan, Phd
• Phone: +86 13648056747
• Email: yuling.yan[@]scu.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices
• Fibrosis
• Liver Cirrhosis
• Liver Stiffness

Intervention

Diagnostic Test:
• Gastroscopy
Gastroscopy

Locations

Country	Name	City	State
China	West China Hospital of Sichuan Univerisity	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver Stiffness	Liver stiffness assessed by 2D-SWE	1 day (At 2D-SWE scanning time)
Primary	Varices stage	Gastroscopy was used to assess varices stage	1 day (At gastroscopy performed time)