Comparative Diagnostic Yield of Contrast-Enhanced Versus Conventional Ultrasound Guidance for Coaxial Biopsy of Hepatic Lesions

NCT07249268 | Completed

• 1 other identifier: XMFHIIT-2025SL218
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared two methods used to guide needle biopsies of suspicious lumps (lesions) in the liver. A biopsy is a procedure where a small sample of tissue is taken to make a diagnosis. Doctors often use standard ultrasound (US) to see the lesion and guide the needle. Another method uses a special dye (contrast agent) injected into a vein during the ultrasound, which is called contrast-enhanced ultrasound (CEUS). The dye helps blood vessels and the lesion "light up" on the screen. The researchers wanted to find out if using CEUS leads to a more successful biopsy than using standard US alone.

Conditions

Hepatic Lesions

Keywords

Liver Biopsy; Focal Liver Lesion; Coarse Needle Biopsy; Contrast-enhanced Ultrasound; Coaxial Biopsy

Outcome Measures

Primary Outcomes (1)

• the biopsy success rate

  the biopsy success rate of liver lesion

  from enrollment to the end of the biopsy

Secondary Outcomes (6)

• vasovagal reaction

  during the procedure

• bleeding

  during the procedure

• pneumothorax

  during the procedure

• shock

  during the procedure

• unplanned hospitalization

  48 hours after the surgery

Study Arms (2)

CEUS Group

CEUS-guided coaxial biopsy for hepatic lesions

Procedure: CEUS or Contrast enhanced Ultrasound

US Group

US-guided coaxial biopsy for hepatic lesions

Procedure: US

Interventions

CEUS or Contrast enhanced Ultrasound PROCEDURE

CEUS-guided coaxial biopsy for hepatic lesions

CEUS Group

US PROCEDURE

US-guided coaxial biopsy for hepatic lesions

US Group

Eligibility Criteria

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

Study Population

Patients underwent CEUS-guided or conventional US-guided coaxial biopsy for focal hepatic lesions.

You may qualify if:

• Indeterminate liver lesions on prior imaging (CT/MRI).
• Coaxial biopsy performed with 18G introducer needle.

You may not qualify if:

• Coagulopathy (INR \>1.5, platelets \<50×109/L).
• Contraindications to ultrasound contrast agents.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

Department of Ultrasound, The First Affiliated Hospital of Xiamen University, 55 Zhenhai Road, Xiamen, China

Xiamen, Fujian, 361000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 25, 2025
• Study Start: January 1, 2022
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)