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Coaxial Needle Sharpness in Liver Biopsy

Comparison of the efficacy and visualization of two types of coaxial needles with different sharpness in liver core-needle biopsy: a randomized trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250422065439N1
Enrollment
67
Registered
2025-06-11
Start date
2025-07-16
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Patients who required liver biopsy were included in the study.. Alcoholic fibrosis and sclerosis of liver

Interventions

Intervention 1: Intervention group: Intervention group: Patients who underwent CNLB using a coaxial needle with an Abrasive Particle Diameter of 80 micrometers, an Abrasive Spray Pressure of 8 bar, a

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged 18 years or older Pwho require a liver biopsy Patients who have provided informed consent

Exclusion criteria

Exclusion criteria: Patients with bleeding disorders Patients with active hepatic infections Patients with any underlying condition that may make biopsy procedures risky Patients with a history of substance abuse Patients undergoing biopsy for a liver mass were excluded, while only those with samples obtained from liver parenchyma were included

Design outcomes

Primary

MeasureTime frame
Pain Intensity: Pain intensity during the biopsy and at different time points (during the procedure, 10 minutes after, 30 minutes after, and at discharge) was measured using the Visual Analog Scale (VAS). This variable serves as the primary outcome for assessing the effect of interventions on pain reduction.Needle Visibility: Needle visibility during the biopsy under ultrasound guidance, subjectively rated on a scale from 0 to 10 by the interventionist, is considered a primary outcome variable for comparing the quality of needle visibility between the different biopsy needles.Number of Portal Tracts Observed in the Tissue Sample: This variable, reported by the pathologist, serves as a primary outcome for comparing the effectiveness of the two types of needles in obtaining adequate tissue samples. Timepoint: Pain Intensity: Pain intensity was measured at four time points:During the biopsy procedure10 minutes after the procedure30 minutes after the procedureAt the time of dischargeNeedle Visibility: Needle visibility was assessed during the biopsy procedure under ultrasound guidance.Number of Portal Tracts: The number of portal tracts in the tissue sample was assessed immediately after the biopsy by the pathologist. Method of measurement: In this study, the primary tools used for performing the biopsy included two types of coaxial needles, which are specified as follows:Needle Type A: The standard coaxial needle used in the control group for performing the biopsy. This needle was used for liver tissue sampling in this study.Needle Type B: The upgraded coaxial needle used in the intervention group. This needle was designed with specific modifications (such as increased sharpness and improved visibility) to enhance the quality of sampling and the needle's visibility under ultrasound guidance.In both groups, these needles were used under the coaxial technique to perform the biopsy.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAlireza Khazen

Mashhad University of Medical Sciences

Alireza.khazen57@gmail.com+98 919 009 1954

Outcome results

None listed

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