Randomized trial of biopsy needle sandblasting in coaxial core-needle liver biopsy: no significant improvement in ultrasound visibility, pain, or tissue yield.

PURPOSE: Optimizing biopsy needle design could enhance procedural performance and patient comfort during core-needle liver biopsy (CNLB). This study aimed to compare a modified biopsy needle with a conventional one in terms of ultrasound visibility, patient-reported pain intensity, and diagnostic tissue yield.

METHODS

In this randomized, triple-blind clinical trial, 70 adult patients scheduled for CNLB at Imam Reza Hospital (Mashhad, Iran) were enrolled and randomly assigned to either a conventional or modified needle group, both of which were commercially available. The modified needle was manufactured by doubling the sandblasting duration, which increased surface roughness and tip sharpness (2.74 to 5.28 Newtons). Pain intensity was measured using the Visual Analogue Scale (VAS) at four time points: during the procedure, 10 min after, 30 min after, and at discharge. The ultrasound visibility and the number of portal tracts in biopsy specimens were assessed independently. Patients requiring intravenous analgesics due to severe pain were excluded from further analysis.

RESULTS

33 participants in the conventional biopsy needle group and 34 in the modified biopsy needle group completed all evaluations. There were no significant differences between groups in terms of age (P = 0.85), sex (P = 0.38), biopsy indication (P = 0.50), ultrasound visibility (P = 0.12), pain intensity at any time point (P > 0.05), and the number of portal tracts in biopsy specimens (P = 0.74). Despite the non-significant differences, both groups demonstrated low pain scores.

CONCLUSION

The modified biopsy needle showed no significant improvement over the conventional needle regarding visibility, patient pain, and tissue adequacy. Therefore, the choice between biopsy needles remains a matter of clinical preference, user familiarity, and cost-effectiveness rather than significant differences in performance.

TRIAL REGISTRATION: IRCT20250422065439N1.