Computed tomography-guided percutaneous biopsy for diagnosing pulmonary nodules: a prospective, multicenter observational study.

Background: Pulmonary nodules are common radiological findings, and accurate diagnosis is essential for patient management and prognosis. Computed tomography (CT)-guided percutaneous biopsy (CTPB) is a minimally invasive and accessible diagnostic method, but its accuracy requires further evaluation. This study assessed the accuracy of CTPBs for diagnosing pulmonary nodules.

Methods: This study involved 591 patients from ten medical centers in China who were prospectively enrolled between April 2021 and April 2022. The primary outcome was the consistency between biopsy pathology results and final clinical diagnosis, while secondary outcomes included the incidence of biopsy-related complications. The data were analyzed via logistic regression and the receiver operating characteristic (ROC) curves.

Results: The 591 patients included in this study had an average age of 59.29±11.22 years, and 50.6% were male. The nodules were categorized as pure ground-glass nodules (10.2%), part-solid nodules (32.0%), and solid nodules (57.9%). The diagnostic accuracy of CTPB for pulmonary nodules was 95.10% (specificity: 100%, sensitivity: 92.79%), the positive predictive value was 100%, and the negative predictive value was 86.76%. Multivariate logistic regression revealed that solid nodules (P<0.001), subsolid nodules [consolidation-to-tumor ratio (CTR) >50%, P=0.001], semiautomatic (tru-cut) needles (P=0.02), number of cuts (P=0.01), intermediate (P=0.006) and peripheral nodules (P=0.02) significantly impacted the diagnostic accuracy of lung nodule biopsy. These factors had predictive value in determining the accuracy of pulmonary nodule biopsy diagnosis (area under the ROC curve: 0.812). The incidence of pneumothorax was 13%, and the incidence of high-grade pulmonary hemorrhage was 27.1%, which did not affect the diagnostic accuracy, while other complications, such as hemopneumothorax (3.6%), pleural reaction (0.7%), and air embolism (0.2%), were rare.

Conclusions: In real-world settings, CTPB diagnoses pulmonary nodules with high accuracy. Improving diagnostic accuracy and reducing the incidence of common complications, such as pneumothorax and pulmonary hemorrhage, are crucial for the widespread application of this technique as a diagnostic tool.