Clinical trial of the Bard CT guide system.

PURPOSE

The Bard computed tomography (CT) guide holds a Monopty gun within the CT gantry and mechanically aids insertion of the needle tip. The clinical efficacy and accuracy of this device, its effect on procedure time, and the limitations of the device were studied.

PATIENT AND METHODS

In a prospective study, the outcome of 107 consecutive biopsies performed with 18-gauge needles was evaluated. In every patient, an attempt was made to perform the biopsy with an 18-gauge Monopty gun positioned with the Bard CT guide and with a hand-held 18-gauge PercuCut needle. Of 107 patients, 73 underwent biopsy with both devices, and 34 underwent biopsy with the PercuCut needle alone.

RESULTS

The device could not be used in 32% of patients, primarily due to patient size or the need to use a lateral approach to a lesion. When the device was used, it positioned the needle within +/- 2 degrees of the programmed angle and at the programmed depth in 96% of cases on the first attempt; the target lesion was hit in 93% of cases (vs 78% with the hand-held needle). Use of the device resulted in a diagnostic biopsy in 84% of cases versus 93% with percuCut needle. This difference was not statistically significant.

CONCLUSION

Despite certain limitations, the Bard CT guide is extremely accurate. Its use decreases the number of times a needle must be repositioned prior to biopsy, thus it would likely reduce the overall procedure time. The diagnostic accuracy of 84% is good and could be improved on by immediately evaluating the specimen cytologically and making additional passes where necessary.