Bin Qiu1, Wanpu Yan1, Keneng Chen1, Xiangning Fu1, Jian Hu1, Shugeng Gao1, Susan Knippenberg1, Michael Schwiers1, Edmund Kassis1, Tengfei Yang1. 1. 1 Department of Thoracic Surgery, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China ; 2 Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), The First Department of Thoracic Surgery, Peking University Cancer Hospital & Institute, Beijing 100142, China ; 3 Department of Thoracic Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan 430030, China ; 4 Department of Thoracic Surgery, The First Affiliated Hospital, Zhejiang University, Hangzhou 310003, China ; 5 Clinical R&D Center of Excellence, 6 Medical Affairs Center of Excellence, Ethicon, Cincinnati, Ohio, USA ; 7 Strategic Medical Affairs, Johnson & Johnson Medical (Shanghai) Ltd., Shanghai 200030, China.
Abstract
BACKGROUND: Lung cancer is one of the most prevalent malignancies worldwide. The number of anatomic lung cancer resections performed via video-assisted thoracoscopic surgery (VATS) is growing rapidly. Staplers are widely used in VATS procedures, but there is limited clinical data regarding how they might affect performance and postoperative outcomes, including air leak. This clinical trial assessed the use of a powered stapler in VATS lung resection, with a primary study endpoint being occurrence and duration of air leak and prolonged air leak (PAL). METHODS: Data was collected from a single arm, multi-center study in Chinese patients receiving VATS wedge resection or lobectomy. Intra-operative data included surgery duration; cartridge selection for ligation/transection of bronchus, major vessels, and lung parenchyma; staple line interventions; blood loss; and device usage. Post-operative data included air leak assessments, chest tube duration, length of hospital stay, and adverse events (AEs). RESULTS: A total of 94 procedures across four institutions in China were included in the final analysis: 15 wedge resections, 74 lobectomies, and five wedge resections followed by lobectomies. Post-operative air leak occurred in five (5.3%) patients who had lobectomy procedures, with PAL in one (1.1%) patient. Sites were generally consistent relative to cartridge use by tissue type. The incidence of stapler firings requiring surgical interventions was seven out of 550 (1.3%). Surgeons participating in the study were satisfied with the articulation and overall usability of the stapler. CONCLUSIONS: The powered staplers make the VATS procedure easier for the surgeons and have achieved intra- and post-operative patient outcomes comparable to those previously reported.
BACKGROUND:Lung cancer is one of the most prevalent malignancies worldwide. The number of anatomic lung cancer resections performed via video-assisted thoracoscopic surgery (VATS) is growing rapidly. Staplers are widely used in VATS procedures, but there is limited clinical data regarding how they might affect performance and postoperative outcomes, including air leak. This clinical trial assessed the use of a powered stapler in VATS lung resection, with a primary study endpoint being occurrence and duration of air leak and prolonged air leak (PAL). METHODS: Data was collected from a single arm, multi-center study in Chinese patients receiving VATS wedge resection or lobectomy. Intra-operative data included surgery duration; cartridge selection for ligation/transection of bronchus, major vessels, and lung parenchyma; staple line interventions; blood loss; and device usage. Post-operative data included air leak assessments, chest tube duration, length of hospital stay, and adverse events (AEs). RESULTS: A total of 94 procedures across four institutions in China were included in the final analysis: 15 wedge resections, 74 lobectomies, and five wedge resections followed by lobectomies. Post-operative air leak occurred in five (5.3%) patients who had lobectomy procedures, with PAL in one (1.1%) patient. Sites were generally consistent relative to cartridge use by tissue type. The incidence of stapler firings requiring surgical interventions was seven out of 550 (1.3%). Surgeons participating in the study were satisfied with the articulation and overall usability of the stapler. CONCLUSIONS: The powered staplers make the VATS procedure easier for the surgeons and have achieved intra- and post-operative patient outcomes comparable to those previously reported.
Entities:
Keywords:
Video-assisted thoracoscopic surgery (VATS); articulation; lobectomy; powered stapler; prolonged air leakage; stapler; wedge resection
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