CT fluoroscopy-guided biopsy of the lung or upper abdomen with a breath-hold monitoring and feedback system: A prospective randomized controlled clinical trial

PURPOSE: To prospectively determine the clinical effectiveness of a breath-hold monitoring and feedback system in computed tomographic (CT) fluoroscopy-guided biopsies in which respiratory motion is a problem. MATERIALS AND METHODS: Institutional review board approval and oral and written informed consent were obtained. This study was HIPAA compliant. A bellows-based system was used to monitor respiration and provide patient feedback. A randomized controlled clinical trial compared intermittent mode CT fluoroscopy-guided biopsies of the lung or upper abdomen performed with (n = 56) and without (n = 57) the bellows system. Inclusion criteria for 113 patients were lesions 6 cm or smaller in maximum dimension that were not affixed to the chest or abdominal wall. Primary outcome measurements were CT fluoroscopy exposure time and patient dose. Wilcoxon rank sum, χ², and Fisher exact tests were used for statistical analysis. RESULTS: Median CT fluoroscopy exposure time was 12.6 seconds (range, 2.4-44.4 seconds) for the bellows group and 18.0 seconds (range, 6.0-118.0 seconds) for the nonbellows group (P = .004). Patient dose was decreased in the bellows group (median dose, 29.5 mGy; range, 4.7-135.8 mGy) versus the nonbellows group (median, 41.3 mGy; range, 11.8-155.9 mGy) (P = .01). Lesions were accessed successfully with one needle puncture attempt in 43 of 56 patients (77%) in the bellows group and 30 of 57 patients (53%) in the nonbellows group (P = .007). Pneumothorax developed in 11 of 50 patients (22%) in the bellows group who underwent lung biopsy compared with 16 of 50 (32%) patients in the nonbellows group. CONCLUSION: A breath-hold monitoring and feedback system allows depiction of mobile target lesions throughout CT fiuoroscopy-guided biopsy of the lung and upper abdomen.