鈴木 秀海

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 ).

BACKGROUND: According to a large-scale clinical trial in Japan, segmentectomy for small peripheral non-small cell lung cancer has an advantage over lobectomy in terms of overall survival, while it could also increase the incidence of local recurrence. In ipsilateral reoperations, intrathoracic adhesions from a previous surgery increase the risk of lung injury and bleeding, which may result in intraoperative and postoperative complications. The ability of oxidized regenerated cellulose (ORC) sheets to prevent postoperative adhesions has been demonstrated in the abdomen, and the same effect is expected in the thoracic region. The purpose of this study is to provide evidence supporting the application of ORC sheets to the parietal pleura of an open chest wounds to prevent postoperative adhesions in the thoracic region. METHODS: This phase II prospective open-label, randomized, parallel-group study will validate adhesion prevention by applying ORC sheets to the parietal pleura of open chest wounds at the time of surgical closure. In the control group, the chest is closed by the usual procedure without ORC sheets. The primary endpoint is the presence rate of pleural adhesion findings on chest echography performed 4-20 weeks postoperatively. Data analysis will be performed in 2025-2026. DISCUSSION: This study will provide evidence to the adhesion prevention effect of ORC sheet in the thoracic region, with the aim of establishing a strategy to prevent postoperative intrapleural adhesions. TRIAL REGISTRATION: This trial has been registered on the Japan Registry of Clinical Trials 1032230271 (https://jrct.niph.go.jp/latest-detail/jRCT1032230271).