Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 3
- 主要终点
- operative time
研究概览
简要总结
Anatomical variations of pulmonary vessel may cause serious problems during pulmonary segmentectomy. Three-dimensional （3D）computed tomography (CT) presents 3D images of pulmonary vessels and the tracheobronchial tree and may help operative planning. Retrospective studies have identified the importance of 3-dimensional CT in the field of pulmonary segmentectomy. And the aim of this study is to compare the usefulness of 3-dimensional CT with standard chest CT in preoperative planning of video-assisted segmentectomy.
详细描述
Lung cancer has been the most serious malignancy around the world which has the highest morbidity and mortality amount all the malignant tumors. Due to the wide spread of lung cancer screening, more and more early stage lung cancer patients have been diagnosed. Video-assisted segmentectomy is a standard surgical procedure in treating early stage peripheral non-small cell lung cancer (NSCLC). However, anatomical variations of pulmonary vessel may cause serious problems, for example unexpected bleed during surgery. Three-dimensional computed tomography (CT), which is reconstructed based on the standard chest CT image, presents 3D images of pulmonary vessels and the tracheobronchial tree and therefore helps operative planning. There are several retrospective studies addressed the importance of 3-dimensional CT in the field of pulmonary segmentectomy. And the aim of this multicenter randomized controlled trial is to compare the usefulness of 3-dimensional CT and standard chest CT in preoperative planning of video-assisted segmentectomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years;
- •Pulmonary nodules or ground glass opacification （GGO） found in chest CT examination, and conform with indications for segmentectomy:
- •Peripheral nodule 0.8-2 cm with at least one of the following:
- •i. Histology of adenocarcinoma in situ; ii. Nodule has ≥50% ground-glass appearance on CT; iii. Radiologic surveillance confirms a long doubling time (≥400 days). Segmentectomy should achieve parenchymal resection margins ≥2 cm or ≥ the size of the nodule.
- •Adequate cardiac function, respiratory function, liver function and renal function for anesthesia and VATS segmentectomy.
- •American Society of Anesthesiologists (ASA) score: Grade I-III.
- •Patients who can coordinate the treatment and research and sign the informed consent.
排除标准
- •Patients with a significant medical condition which is thought unlikely to tolerate the surgery. For example, cardiac disease, significant liver and renal function disorder.
- •Patients with psychiatric disease who are expected lack of compliance with the protocol.
- •Patients have history of chest trauma or surgery on ipsilateral chest which may cause pleural adhesion.
研究组 & 干预措施
Chest computed tomography
Chest contrast-enhanced computed tomography will be performed preoperatively. Video-assisted segmentectomy will be performed based on the image of preoperative chest CT
3D Reconstruction
Chest contrast-enhanced computed tomography will be performed preoperatively, and 3-dimensional reconstruction will be formed based on the data of chest CT. Video-assisted segmentectomy will be performed guided by the image of 3-dimensional CT. IPS-lung software (Shenzhen Yorktal Digital Medical Imaging Technology Company, Shenzhen, China) will be used preoperatively to construct a 3D-image to ascertain the position and structure of targeted segmental blood vessels and bronchi.
干预措施: 3D reconstruction (Other)
结局指标
主要结局
operative time
时间窗: During surgery
the time of operation
次要结局
- Duration of chest tube placement(Up to 4 weeks)
- Postoperative hospital stay(Up to 24 weeks)
- conversion rate(During surgery)
- 30-day mortality(Postoperative in-hospital stay up to 30 days)
- blood loss(During surgery)
- Incidence of postoperative complications(Postoperative in-hospital stay up to 30 days)
- Disease-free survival （DFS）(up to 60 months)
- operative accident event(During surgery)
- dissection of lymph nodes(2 weeks after surgery)
- Preoperative lung function(Baseline)
- Postoperative lung function(at the 3rd month after surgery)
- Overall survival (OS)(up to 60 months)
- Incidence of change of surgical plan(During surgery)
研究者
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital