A randomized controlled trial of bronchial occlusion therapies with silicon spigots or fibrin glue against intractable spontaneous pneumothorax

Background: An increasing number of spontaneous pneumothorax patients have been receiving bronchial occlusion therapies (BOTs) using the Endobronchial Watanabe Spigot (EWS ®, Novatech©, France), a small piece of silicon with a studded surface designed to prevent migration. However, the effectiveness of the EWS in patients with intractable pneumothorax is yet unknown. Methods: Inoperable pneumothorax patients who experienced air leakage from their chest tubes for more than 3 days were randomly assigned to receive BOT by a bronchoscopy either with the EWSs or the fibrin glue. The success of the BOT was defined as the termination of air-leakage from the chest tubes and expansion of the affected lungs within a week of the first, or second BOT. If the initial BOT was unsuccessful, the patients could elect to undergo a second round of therapy one week after the first round using either the EWS or the fibrin glue regardless of which was used initially. Results: No significant difference was found in the termination, or duration of air-leakage between the EWS group and the fibrin glue group (5/10 vs 4/12 cases, p=0.67; 10 [0-80] vs 14 [0-223] days, p=0.65, respectively). Also, no significant difference was found in the frequency of adverse events such as fever and pneumonia between the two groups. Conclusion: The results suggested that EWSs offered no significant benefit with respect to the termination of air-leakage in bronchial occlusion therapy against intractable spontaneous pneumothorax when compared with fibrin glue. (Funded by Tokyo Metropolitan Government; UMIN Clinical Trials Registry, UMIN000009774).