A Lung Biopsy Tract Plug for Reduction of Postbiopsy Pneumothorax and Other Complications: Results of a Prospective, Multicenter, Randomized, Controlled Clinical Study

Purpose To evaluate the ability of an expanding hydrogel lung biopsy tract plug (“plug”) to reduce rates of pneumothoraces and other complications associated with computed tomography (CT)-guided lung biopsy. Materials and Methods A total of 339 subjects (mean age, 67 years) who underwent lung biopsy of indeterminate masses, without immediate postsample CT evidence of a pneumothorax, were randomized at 15 U.S. centers. Treatment subjects ( n = 170) received a plug deployed through the coaxial needle just before the needle was removed. Control subjects ( n = 169) did not receive a plug. The primary end point was defined as the absence of pneumothorax on chest radiographs at all three required postprocedure assessments (30- to 60-minute, 24-hour, 30-day); analysis was stratified by any smoking history and study site. A central laboratory performed blinded independent interpretation of the radiographs. Results Among the 287 subjects who completed all postprocedure assessments, significantly more treatment subjects than control subjects achieved the primary end point (127 of 150, 85% vs 95 of 137, 69%; P = .002). Among all 339 randomized subjects, the odds of achieving the primary end point were 4.4 times greater for nonsmokers than they were for smokers (95% confidence interval, 1.7, 11.0; P = 0.002); study site had no statistically significant effect. Compared with control subjects, treatment subjects had fewer pneumothoraces (30 of 170, 18% vs 53 of 169, 31%), fewer chest tubes placed (6 of 170, 4% vs 18 of 169, 11%), and fewer postbiopsy hospital admissions (16 of 170, 9% vs 23 of 169, 14%). Conclusions The lung biopsy tract plug significantly reduced rates of pneumothorax in patients undergoing CT-guided lung biopsy. Rates of chest tube placement and postprocedure hospital admission were also reduced.