Clinical trial NCT03989973: Two-dimensional Shear-Wave Elastography Evaluate Esophageal Varices Bleeding Risk of Liver Cirrhosis
Official title: West China Hospital, Sichuan University
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Esophageal Varices
Liver Stiffness
Keywords: Liver cirrhosis
Esophageal Varices
Liver Stiffness
Spleen Stiffness
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: compensated cirrhosis

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Liver Stiffness
timeFrame: 1 day (At 2D-SWE scanning time)
measure: Varices stage
timeFrame: 1 day (At gastroscopy performed time)
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan Univerisity
state: Sichuan
Study officials:
affiliation: West China Hospital of Sicuan Univerisity
name: Xuefeng Luo
role: PRINCIPAL_INVESTIGATOR
References: