3D Reconstruction in Video-assisted Thoracoscopic Surgery (VATS) Segmentectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy

Conditions
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Segmentectomy

Intervention / Treatment
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* Other: 3D reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D Reconstruction<br>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. | Other: 3D reconstruction<br>* 3-dimensional computed tomography reconstruction guided VATS segmentectomy<br>|
| No Intervention: Chest computed tomography<br>Chest contrast-enhanced computed tomography will be performed preoperatively. Video-assisted segmentectomy will be performed based on the image of preoperative chest CT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time | the time of operation | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss | Amount of intraoperative blood loss | During surgery | 
| conversion rate | the rate of conversion to open surgery in the operation | During surgery | 
| operative accident event | the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy | During surgery | 
| Incidence of postoperative complications | mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula | Postoperative in-hospital stay up to 30 days | 
| Postoperative hospital stay | length of stay in hospitalization | Up to 24 weeks | 
| Duration of chest tube placement | Duration of chest tube placement | Up to 4 weeks | 
| 30-day mortality | 30-day mortality after surgery | Postoperative in-hospital stay up to 30 days | 
| dissection of lymph nodes | including overall lymph node count, number of stations dissected and number of lymph nodes in each lymph node station | 2 weeks after surgery | 
| Overall survival (OS) | Up to the date of death of any causes since the date of randomization | up to 60 months | 
| Disease-free survival （DFS） | Up to the date of disease recurrence since the date of randomization | up to 60 months | 
| Preoperative lung function | forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre | Baseline | 
| Postoperative lung function | forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre | at the 3rd month after surgery | 
| Incidence of change of surgical plan | 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 | During surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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segmentectomy, Video-assisted thoracoscopic surgery, lung cancer, ground-glass opacity