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A prospective multi-center clinical study of liver biopsy with full core biopsy and side-cutting biopsy.

A prospective multi-center clinical study of liver biopsy with full core biopsy and side-cutting biopsy.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081578
Enrollment
Unknown
Registered
2024-03-05
Start date
2023-04-30
Completion date
Unknown
Last updated
2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diffused hepatic lesions

Interventions

fully automatic core biopsy needle group:The study compares the use of a fully automatic core biopsy needle in the fully core biopsy group and a fully automatic side-notch biopsy needle in the side-no
side-cutting biopsy needle group:The study compares the use of a fully automatic core biopsy needle in the fully core biopsy group and a side-cutting biopsy needle group. Both groups use an 18G biopsy

Sponsors

West China Hospital,Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Unexplained liver function abnormalities, cirrhosis, and the need to determine the presence of liver fibrosis or cirrhosis in clinical situations. Unexplained hepatomegaly (enlarged liver). Timing selection for antiviral treatment in patients with chronic hepatitis B (assessing the extent of liver fibrosis or inflammation) and evaluating treatment efficacy, monitoring, and prognosis. Consideration of autoimmune liver diseases, including autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, and overlapping syndromes. Consideration of genetic metabolic liver diseases (such as Wilson disease, hereditary hemochromatosis, alpha-1 antitrypsin deficiency, etc.), where liver biopsy assists in diagnosis and treatment planning. Diagnosis of alcoholic liver disease and non-alcoholic fatty liver disease, as well as determining the degree of liver tissue fibrosis. Post-liver transplant patients, when considering complications such as rejection reactions or infections. Other patients requiring liver biopsy as determined through multidisciplinary consultations.

Exclusion criteria

Exclusion criteria: Extrahepatic obstructive jaundice. Significant bleeding tendency (meeting either of the following criteria: prolonged prothrombin time (PT) > 3 seconds and/or platelet count < 50×109/L). Comatose or non-cooperative patients with other illnesses. Presence of infectious lesions along the puncture path.

Design outcomes

Primary

MeasureTime frame
Number of puncture;Puncture empty needle rate;Puncture sample quality;

Secondary

MeasureTime frame
Pathological diagnosis rate;Consistency of pathological and clinical diagnosis results;

Countries

China

Contacts

Public ContactQiang Lu

West China Hospital,Sichuan University

luqiang@scu.edu.cn+86 138 8217 5090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026