3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy
- Conditions
- Segmentectomy
- Interventions
- Other: 3D reconstruction
- Registration Number
- NCT04004494
- Lead Sponsor
- Ruijin Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
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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.
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American Society of Anesthesiologists (ASA) score: Grade I-III.
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Patients who can coordinate the treatment and research and sign the informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3D Reconstruction 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.
- Primary Outcome Measures
Name Time Method operative time During surgery the time of operation
- Secondary Outcome Measures
Name Time Method Duration of chest tube placement Up to 4 weeks Duration of chest tube placement
Postoperative hospital stay Up to 24 weeks length of stay in hospitalization
blood loss During surgery Amount of intraoperative blood loss
Incidence of postoperative complications Postoperative in-hospital stay up to 30 days mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Preoperative lung function Baseline forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre
conversion rate During surgery the rate of conversion to open surgery in the operation
30-day mortality Postoperative in-hospital stay up to 30 days 30-day mortality after surgery
Disease-free survival （DFS） up to 60 months Up to the date of disease recurrence since the date of randomization
Postoperative lung function at the 3rd month after surgery forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre
operative accident event During surgery the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy
dissection of lymph nodes 2 weeks after surgery including overall lymph node count, number of stations dissected and number of lymph nodes in each lymph node station
Overall survival (OS) up to 60 months Up to the date of death of any causes since the date of randomization
Incidence of change of surgical plan During surgery Surgical plan is made based of the image of standard chest computed tomography or three-dimensional computed tomography, the targeted segmental bronchus and pulmonary vessels are decided preoperatively. Change of surgical plan is recorded when the actually resected bronchus and vessels are different to those in the preoperative surgical plan
Trial Locations
- Locations (3)
Guangdong General Hospital
🇨🇳Guangdong, Guangdong, China
Union Hospital of Fujian medical university
🇨🇳Fujian, Fujian, China
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
🇨🇳Shanghai, Shanghai, China