A Randomized Controlled Trial of Non-intubated Versus Intubated VATS for Mediastinal Neoplasm
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Conversion rate to open surgery
研究概览
简要总结
In recent year, non-intubated anesthesia had emerged as an available and promising alternative for thoracic procedure. However, its safety and feasibility in video-assisted thoracoscopic surgery (VATS) for mediastinal neoplasm remain controversial. This randomized controlled trial is designed to evaluate the impact of the non-intubated approach on surgical and perioperative outcomes in patients undergoing mediastinal neoplasm resection.
详细描述
Non-intubated anesthesia has gained widespread adoption in recent years, representing a significant advancement in both thoracic surgery and anesthetic practice. The surgical safety and feasibility of tubeless VATS for mediastinal neoplasm has been confirmed. However, the oncological long-term outcomes of RATS lobectomy has not been studied by randomized controlled trial. Accordingly, this randomized controlled trial aims to evaluate whether the non-intubated approach provides comparable short-term and long-term outcomes to the conventional intubated technique in VATS for mediastinal neoplasm resection.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mediastinal neoplasm was diagnosed by chest enhanced CT
- •The patients with age ≥ 18 and ≤ 80 years old
- •The patients whose tumor diameter was <6 cm
- •ASA grade: I-III
- •The patients should understand the research and sign the informed consent
排除标准
- •Imaging examinations revealed that the tumor had invaded adjacent organs, with evidence of pleural or pericardial dissemination, as well as lymphatic and/or hematogenous metastases
- •Patients with a confirmed history of congestive heart failure, poorly controlled angina despite medical therapy, electrocardiogram-confirmed myocardial infarction with transmural involvement, uncontrolled hypertension, clinically significant valvular heart disease, or high-risk arrhythmias not adequately managed
- •Patients with concurrent active malignancies
结局指标
主要结局
Conversion rate to open surgery
时间窗: postoperative in-hospital stay up to 30 days
Proportion of patients requiring conversion from VATS to open surgery.
Postoperative complication rate
时间窗: postoperative in-hospital stay up to 30 days
Incidence and severity of treatment-related adverse events, classified by Clavien-Dindo for surgical complications and CTCAE v5.0 for systemic adverse events.
Conversion rate to intubated anesthesia
时间窗: postoperative in-hospital stay up to 30 days
Proportion of patients requiring conversion from non-intubated approach to intubated anesthesia
次要结局
- R0 rate(postoperative in-hospital stay up to 30 days)
- 1-year disease-free survival (DFS)(1 year after surgery)
- Operation time(postoperative in-hospital stay up to 30 days)
- Hospital stay(postoperative in-hospital stay up to 30 days)
- Intraoperative bleeding loss(postoperative in-hospital stay up to 30 days)
- ICU stay(postoperative in-hospital stay up to 30 days)
- Volume of postoperative drainage(postoperative in-hospital stay up to 30 days)
- 1-year overall survival(OS)(1 year after surgery)
- Quality of life (QOL) at 3 month(Quality of life (QOL) at 3 months post-discharge, as measured by [specify QOL scale], reflecting patient-reported physical, emotional, and social well-being.)
研究者
Shuben Li
Deputy Director
The First Affiliated Hospital of Guangzhou Medical University