Safety, feasibility and efficacy of 2% polidocanol in endobronchial sealing of bronchopleural fistulae – Phase 2 interventional clinical trial

Introduction: Broncho-pleural fistula (BPF) is rare but serious complication following thoracic surgery. Primary goal of this trial was determination of safety and feasibility of endobronchial sealing of the BPF with 2% polidocanol. Secondary objective was determination of the procedural efficacy. Methods: This was a phase II interventional trial that recruited 15 patients with BPF. Endobronchial sealing was performed by submucosal application of 1-2 mL of 2% polidocanol through TBNA needle. Number of punctures and procedures were determined on case by case basis. Selected patient, procedure and technique related factors were evaluated for multivariate analysis regarding efficacy. Results: Incidence of BPF in investigated study population was 1.12%. Endobronchial sealing was successful in 80% (12/15) patients. Mean age of the patients was 54±16 years, mean size of fistulae 7±5.5 mm, duration of intervention 20±3 minutes, number of punctures 9±6, number of interventions 1.5, time from surgery 42±34 days, time to closure 10±9 days. In majority of patients age under 50 years, male gender, non-smoking status, absence of respiratory co-morbidity and lobectomy led to bronchoscopic sealing. Neoadjuvant therapy, shorter time from surgery and positive margins led to failure of bronchoscopic sealing. Size of fistula (p=0.018) and time to closure (p=0.004) were significantly correlated to success of bronchoscopic sealing. We did not observe any procedure-related adverse effects. Conclusion: Endobronchial sealing with 2% polidocanol is safe, feasible and possibly very efficient technique for treatment of BPF.