A lung biopsy tract plug for reduction of postbiopsy pneumothorax and other complications: results of a prospective, multicenter, randomized, controlled clinical study

Abstract

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.

Trial registration: ClinicalTrials.gov NCT00527722.