A Prospective, Multi-Center Evaluation of a Powered Surgical Stapler in Video-Assisted Thoracoscopic Lung Resection Procedures in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- Occurrence of Prolonged Air Leaks
研究概览
简要总结
Collection of real world outcomes of Video-Assisted Thoracoscopic Surgery (VATS) for lung cancer (lobectomy, wedge resection) using ECHELON FLEX™ Powered ENDOPATH® Staplers 45 mm and/or 60 mm (study devices) in a Korean population.
详细描述
This clinical trial assessed the use of a powered stapler for transection in VATS lung resection, where there is currently limited published clinical data. The primary study endpoint was occurrence and duration of air leak / prolonged air leak (PAL). Procedure details and perioperative outcomes associated with VATS lung resections were also evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or confirmed of NSCLC (up to and including Stage II), or individuals undergoing VATS diagnostic wedge resection in accordance with their institution's Standard of care (SOC);
- •Scheduled for lung resection surgery (lobectomy or wedge resection) involving only one lobe of the lung;
- •Performance status 0-1 (Eastern Cooperative Oncology Group classification);
- •ASA score ≤ 3;
- •No prior history of VATS or open lung surgery;
- •Willing to give consent and comply with study-related evaluation and treatment schedule; and
- •At least 19 years of age.
排除标准
- •Active (subject currently receiving systemic treatment) bacterial infection or fungal infection;
- •Systemic administration (intravenous or oral) of steroids, including herbal supplements that contain steroids, (within 30 days prior to study procedure);
- •Chemotherapy or radiation therapy for lung cancer may not be performed for 30 days prior to the procedure;
- •Scheduled concurrent surgical procedure other than wedge resection or lobectomy (central venous access - e.g., port placement, mediastinoscopy with lymph node sampling, and VATS lymphadenectomy are allowed);
- •Pregnancy;
- •Physical or psychological condition which would impair study participation;
- •The patient is judged unsuitable for study participation by the Investigator for any other reason; or
- •Unable or unwilling to attend follow-up visits and examinations.
结局指标
主要结局
Occurrence of Prolonged Air Leaks
时间窗: Post-operative period through hospital discharge and follow-up at Day 30
Prolonged air leaks defined as longer than 5 days in continuous duration. Air leak was to be quantitatively assessed starting on the evening after surgery and then twice daily (during morning and evening rounds). Patients were instructed to perform standardized repeated forced expiratory maneuvers (coughing and blowing).
次要结局
- Occurrence of Postoperative Air Leaks(Post-operative period through hospital discharge and follow-up at Day 30)
- Length of Stay (LOS)(Post-operative period through hospital discharge and follow-up at Day 30)
- Volume of Estimated Intra-operative Blood Loss(Blood loss intra-op and up to 5 days post-op)
- Time to Chest Tube Removal(Post-operative period through hospital discharge and follow-up at Day 30)