A Multicenter, Randomized, Parallel-Group Trial Evaluating Progel Platinum Added to Mechanical Stapling Versus Mechanical Stapling Alone in Patients Undergoing VATS Upper or Lower Lobectomy for Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Duration of pleural drainage
研究概览
简要总结
This multicenter randomized trial evaluates whether routine use of Progel Platinum surgical sealant on stapled fissure lines during VATS upper or lower lobectomy for NSCLC reduces pleural drainage duration compared with standard stapling alone. Secondary objectives include postoperative length of stay, incidence and duration of postoperative air leaks, residual pleural space, safety outcomes, and hospitalization costs.
详细描述
Lobectomy is the standard surgical treatment for many patients with early-stage NSCLC, but postoperative air leak remains a frequent complication associated with prolonged chest tube duration, longer hospitalization, and increased healthcare costs. Preliminary non-randomized evidence suggests that Progel Platinum may improve intraoperative sealing of fissure lines and reduce postoperative air leaks. E-SEAL is a prospective, randomized, controlled, multicenter study in 8 thoracic surgery centers. Eligible adult patients undergoing minimally invasive VATS upper or lower lobectomy for NSCLC are randomized 1:1 to stapling alone or stapling plus Progel Platinum. The primary endpoint is pleural drainage duration in hours. Secondary endpoints include postoperative length of stay, hospitalization costs, postoperative air leak incidence and volume, residual pleural space, complications, re-interventions, and follow-up outcomes up to 60 days after surgery/discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Written informed consent
- •Planned VATS upper or lower lobectomy for NSCLC
- •Minimally invasive thoracoscopic approach
- •Middle lobectomy excluded
排除标准
- •Induction radiochemotherapy or chemo-immunotherapy
- •Severe COPD: GOLD 3 or higher
- •Sleeve resection or extended resection involving other lobes/chest wall/pericardium, etc.
- •Albumin intolerance/allergy
- •Renal insufficiency
- •Redo surgery
- •Use of sealants/adhesives other than the study approach
- •Expected extensive pleural adhesions
研究组 & 干预措施
Progel Group (PG)
Fissure completion with mechanical staplers followed by application of Progel Platinum sealant along the fissure completion line.
干预措施: Progel Platinum (Device)
Standard Treatment Group (ST)
Fissure completion with mechanical staplers alone, according to current standard practice.
干预措施: Mechanical Stapling (Procedure)
结局指标
主要结局
Duration of pleural drainage
时间窗: From surgery to chest tube removal, assessed up to 30 days after surgery
Time from surgery to chest tube removal, measured in hours.
次要结局
- Postoperative hospital length of stay(From surgery to hospital discharge, assessed up to 30 days after surgery)
- Incidence and volume of postoperative air leaks(Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery)
- Incidence of residual pleural space(During postoperative hospitalization and at follow-up visits at 1 month and 2 months after discharge)
- Postoperative safety outcomes(During postoperative hospitalization and up to 30 days after surgery)
- Duration of postoperative air leak(From surgery to resolution of postoperative air leak during postoperative hospitalization, assessed up to 30 days after surgery)
- Duration of surgical procedure(During the surgical procedure)
- Mean daily and total postoperative air leak volume(Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery)
- Air leak indices corrected for length of dissected pulmonary parenchyma(Daily during postoperative hospitalization, from surgery until chest tube removal or hospital discharge, assessed up to 30 days after surgery)