Evaluating air leakage from staple line reinforcements in anatomical pulmonary resection (AIRSTOP): a prospective randomized controlled trial protocol

Abstract

Background Air leakage during pulmonary resection is a major complication in thoracic surgery. It frequently occurs at sites of adhesion dissection, due to lung manipulation, and along the staple lines of automatic suturing devices, particularly in cases of pulmonary fragility such as those of emphysema and interstitial pneumonia. Persistent postoperative air leakage prolongs chest tube indwelling and extends hospitalization time. Staplers with absorbable tissue reinforcements have been introduced for pulmonary resection to prevent intraoperative stapler-related air leakage. This phase II prospective, open-label, randomized, parallel-group trial aims to validate the efficacy of staplers with or without absorbable tissue reinforcements in controlling stapler-related air leakage during anatomical pulmonary resections. Methods Overall, 120 patients will be randomized into two groups: one that will undergo conventional anatomical pulmonary resection and the other in which staplers with absorbable tissue reinforcements will be used. The primary endpoint will be intraoperative stapler-related air leakage. Data will be analyzed between 2024 and 2025. Discussion This trial will validate the effectiveness and safety of staple line reinforcements in controlling intraoperative air leakage during anatomical pulmonary resections, potentially leading to optimized strategies for patients with conditions such as emphysema and interstitial pneumonia. Trial registration This trial has been registered with the Japan Registry of Clinical Trials 1032220620 (https://jrct.niph.go.jp/latest-detail/jRCTs031230224).