Multicenter, prospective, observational study of a novel technique for preoperative pulmonary nodule localization.

ABSTRACT

OBJECTIVES: Minimally invasive surgery provides an ideal method for pathologic diagnosis and curative intent of small pulmonary nodules (SPNs); however, the main problem with thoracoscopic resection is the difficulty in locating the nodules. The goal of this study was to determine the safety and feasibility of a new localization technique tailored for SPNs. METHODS: A computed tomography (CT)-guided technique, which has a tri-colored suture and claw with 4 fishhook-shaped hooks, was designed to localize SPN preoperatively. Then a multicenter, prospective study was conducted to evaluate the safety and feasibility of this device. The primary endpoints included safety (asymptomatic/symptomatic pneumothorax or parenchymal hemorrhage, and unanticipated adverse effects) and success rate (precise placement and device fracture, displacement, or dislodgement). The secondary endpoints included feasibility (duration of the localization procedure and device fracture or fault) and patient comfort (pain). RESULTS: A total of 90 SPNs were localized from 80 patients. Overall, no symptomatic complications requiring medical intervention, with the exception of asymptomatic pneumothorax (n = 7 [7.8%]) and lung hemorrhages (n = 5 [5.6%]), were observed. The device was successfully placed without dislodgment or movement in 87 of 90 lesions (96.7%). The median nodule size was 0.70 cm (range, 0.30-1.0 cm). The median duration of the procedure was 15 minutes (range, 7-36 minutes). No patient complained of notable pain during or after the procedure. CONCLUSIONS: This new device for SPNs is safe, and has a high success rate, feasibility and good tolerance.