Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Complications
研究概览
简要总结
According to published studies, there are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.
详细描述
Lung cancer has been one of the most serious life-threatening diseases of human society. It has the highest morbidity and mortality worldwide among all the malignant tumors. Due to the popularization of low-dose CT and other means of examination, more and more patients with lung cancer are detected in the early phase of disease. Anatomical segmentectomy is one of the standard surgical procedures for these small pulmonary nodules or ground glass opacity (GGO), which are clinically highly suspected or puncture confirmed early lung cancer lesions. Dissection of the intersegmental plane in segmentectomy is a difficulty that have puzzled thoracic surgeons for decades because of the complicated anatomic relationship and variations, along with lack of boundary between pulmonary segments. There are two main approaches in the dissection of intersegmental plane: stapling devices and energy instrument separation. However, only a few retrospective studies focused on the perioperative outcomes of these two approaches in segmentectomy, not to mention in robot assisted segmentectomy, and there has been no definitive conclusion about which method is better. So the investigators want to conduct a prospective study, trying to figure out this problem.
The investigators set incidence rate of postoperative complications as their primary endpoint. According to their calculation, a total of 136 patients will be enrolled (each group has 68 patients).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 70 years old;
- •Pulmonary nodules or GGO found in chest CT examination, and conform with indications for segmentectomy mentioned in NCCN guidelines:
- •Poor pulmonary reserve or other major comorbidity that contraindicates lobectomy;
- •Peripheral nodule ≤2 cm with at least one of the following:
- •Pure (Adenocarcinoma in situ) AIS histology;
- •Nodule has ≥50% ground-glass appearance on CT;
- •Radiologic surveillance confirms a long doubling time (≥400 days).
- •Normal in preoperative tests, such as blood routine examination, liver function, renal function, coagulation function, etc.
- •ASA score: Grade I-III.
- •Patients who can coordinate the treatment and research and sign the informed consent.
排除标准
- •Patients have history of malignant tumor, or have accepted neoadjuvant chemotherapy and(or) radiotherapy.
- •Patients have comorbidities in cardiovascular, kidney, lung or hematopoietic system, who cannot tolerate the surgery.
- •Psychiatric patients。
- •Patient have history of chest trauma or surgery on ipsilateral chest.
研究组 & 干预措施
Energy Instruments Group
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
干预措施: Energy Instruments (Device)
Stapling Device Group
All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed.
干预措施: Stapling Device (Device)
结局指标
主要结局
Incidence of Postoperative Complications
时间窗: postoperative in-hospital stay up to 30 days
The primary outcome was the incidence of postoperative complications, including air leakage (defined as a rate of air flow \>50 mL/min lasting more than 3 days), atelectasis (visible on chest X-rays with complaints), hemorrhage (bloody drainage more than 200 mL for 3 consecutive hours), pulmonary infection (visible on chest X-rays with complaint), and pulmonary embolism (confirmed by CT scan).
次要结局
- Duration of Surgery(During surgery)
- Number of Conversions(During surgery)
- Postoperative Hospital Stay(up to 24 weeks)
- Postoperative ICU Stay(up to 24 weeks)
- Incidence Rates of Each Postoperative Complications(postoperative in-hospital stay up to 30 days)
- Preoperative Lung Function(Baseline.)
- Postoperative Lung Function at the 3rd Month After Surgery(at the 3rd month after surgery)
- Duration of Drainage(up to 4 weeks)
- Drainage Volume of the First Day After Surgery(First day after surgery)
- Daily Air Leakage Volume(During drainage time, up to 4 weeks)
- Blood Loss During Surgery(During surgery)
- Participants With Malignant Tumors(2 weeks after surgery)
- Medical Costs(During hospital stay, up to 24 weeks)
- Mortality in 30 Days After Surgery(postoperative in-hospital stay up to 30 days)
研究者
Hecheng Li M.D., Ph.D
Professor
Ruijin Hospital