Methods of Establishing Intersegmental Plane in Segmentectomy: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Operative time required for segmentectomy
研究概览
简要总结
The aim of this study is to perform a prospective, single-center, randomized controlled study to explore whether closed insufflation technique is not inferior to dilatation and collapse technique in segmentectomy, and to provide a new option for establishing intersegmental plane in segmentectomy.
详细描述
This is a single-center, prospective, randomized controlled study. A total of 200 subjects undergoing segmentectomy are scheduled to be enrolled within 1 year, and the subjects are randomly divided into closed insufflation group or dilatation and collapse group using a random number table generated by the computer, with 100 cases in each group. Intersegmental plane resolution grading, perioperative complications, operative time, intraoperative blood loss, postoperative hospitay stay, and pulmonary function 3 months and 1 year after surgery will be extracted and compared between the groups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients voluntarily join and sign a written informed consent;
- •The age of the subjects is 18-75 years old, regardless of gender;
- •The ECOG PS was 0 or 1;
- •Three-dimensional visualization was performed before surgery, and the surgeon judged that the tumor could be completely removed by segmentectomy, and surgical margin was expected to be greater than 2cm or the maximum diameter of the nodule;
- •Thin-slice CT suggests any of the following: ① The diameter of pulmonary nodules is 2-3cm and the consolidation-tumor ratio (CTR) is less than 0.25; ② Pulmonary nodule diameter ≤2cm and 0.25 < CTR < 0.5; ③ Non-peripheral pulmonary nodule diameter ≤2cm and CTR≤0.25;
- •cN0 and no distant metastasis;
- •Intraoperative freezing examination or postoperative paraffin examination suggest early lung adenocarcinoma;
- •Intraoperative freezing disease of station 12 lymph nodes showed no cancer metastasis;
- •Preoperative anesthesia risk assessment: American Society of Anesthesiologists (ASA) Level I-III;
- •Has no history of lung resection;
- •Has not received anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy and immunotherapy.
排除标准
- •The subject did not understand the study protocol, did not cooperate or refused to sign the informed consent;
- •The subject has a history of malignant tumor or has previously received anti-tumor therapy;
- •3D visualization was not received before surgery;
- •The surgeon judged that segmentectomy could not ensure complete resection of the tumor;
- •has a history of lung resection, or chest trauma or surgery on the affected side of chest cavity;
- •Extensive intraoperative dense thoracic adhesion;
- •Conversion to thoracotomy;
- •Intraoperative frozen examination of intrapulmonary lymph nodes indicated cancer metastasis;
- •Pulmonary nodules are located in the right middle lung;
- •Suffered from chronic bronchitis, emphysema, asthma and other chronic lung diseases;
- •Other conditions unsuitable for inclusion in this study deemed by the researcher.
研究组 & 干预措施
Closed insufflation technique group
Closed insufflation technique is characterized by ligation in the proximal portion of targeted bronchus and gas injection in the distal portion. Closed insufflation technique group includes patients undergoing segmentectomy using closed insufflation technique.
干预措施: Implementation of closed insufflation technique during segmentectomy (Procedure)
Dilatation and collapse technique
Dilatation and collapse technique is characterized by pure oxygen dilatation and subsequent collapse after the division of targeted bronchus. Dilatation and collapse technique group includes patients undergoing segmentectomy using Dilatation and collapse technique.
干预措施: Implementation of dilatation and collapse technique during segmentectomy (Procedure)
结局指标
主要结局
Operative time required for segmentectomy
时间窗: From the dissection of segmental structures to finish of segementectomy
Operative time required for segmentectomy will be measured as the total minutes from initiation to completion of segmentectomy.
Surgical complications
时间窗: Up to 3 months
Surgical complications will be assessed according to the Society of Thoracic Surgeons database criteria.
Intersegmental plane clarity grading
时间窗: intraoperatively
Intersegmental plane clarity will be graded as followed: G1: partial collapse of targeted parenchymal tissue, G2: partial dilatation of non-targeted adjacent tissue, G3: dilatation of targeted tissue and unclearness of intersegmental plane, G4: entire dilatation of targeted tissue and clearness of intersegmental plane.
Pulmonary function 3 months and 1 year after surgery
时间窗: Up to 1 year
Pulmonary function includes ventilation and diffusion function. Pulmonary function will be measured at two time points including 3 months and 1 year after surgery.
次要结局
- Intraoperative blood loss(Intraoperatively)
- Volume of targeted parenchymal tissue(Up to 3 days)
- Postoperative hospital stay(Up to 2 weeks)
- Days of chest tube placement(Up to 2 weeks)
- Safety margin(Up to 1 week)
研究者
Liu Wenliang
Professor
Second Xiangya Hospital of Central South University