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

NCT03989973 | Unknown DMC

• 1 other identifier: 2D-SWE evaluate varices
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis; Esophageal Varices; Liver Stiffness

Keywords

Liver cirrhosis; Esophageal Varices; Liver Stiffness; Spleen Stiffness

Outcome Measures

Primary Outcomes (2)

• Liver Stiffness

  Liver stiffness assessed by 2D-SWE

  1 day (At 2D-SWE scanning time)

• Varices stage

  Gastroscopy was used to assess varices stage

  1 day (At gastroscopy performed time)

Study Arms (1)

Cirrhosis patients

Patients were diagnosed by liver biopsy, CT or ultrasound

Diagnostic Test: Gastroscopy

Interventions

Gastroscopy DIAGNOSTIC_TEST

Gastroscopy

Cirrhosis patients

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

compensated cirrhosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan Univerisity

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Esophageal and Gastric Varices

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Xuefeng Luo

  West China Hospital of Sicuan Univerisity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuling Yan, Phd

CONTACT

+86 13648056747; yuling.yan@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 18, 2019
• Study Start: September 1, 2016
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)