Segmentectomy
Conditions
Keywords
segmentectomy, Video-assisted thoracoscopic surgery, lung cancer, ground-glass opacity
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.
Interventions
OTHER3D reconstruction
3-dimensional computed tomography reconstruction guided VATS segmentectomy
Sponsors
Union hospital of Fujian Medical University
Guangdong Provincial People's Hospital
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age older than 18 years; 2. 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. 3. Adequate cardiac function, respiratory function, liver function and renal function for anesthesia and VATS segmentectomy. 4. American Society of Anesthesiologists (ASA) score: Grade I-III. 5. Patients who can coordinate the treatment and research and sign the informed consent.
Exclusion criteria
1. Patients with a significant medical condition which is thought unlikely to tolerate the surgery. For example, cardiac disease, significant liver and renal function disorder. 2. Patients with psychiatric disease who are expected lack of compliance with the protocol. 3. Patients have history of chest trauma or surgery on ipsilateral chest which may cause pleural adhesion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operative time | During surgery | the time of operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood loss | During surgery | Amount of intraoperative blood loss |
| conversion rate | During surgery | the rate of conversion to open surgery in the operation |
| operative accident event | During surgery | the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy |
| Incidence of postoperative complications | Postoperative in-hospital stay up to 30 days | mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula |
| Postoperative hospital stay | Up to 24 weeks | length of stay in hospitalization |
| Duration of chest tube placement | Up to 4 weeks | Duration of chest tube placement |
| 30-day mortality | Postoperative in-hospital stay up to 30 days | 30-day mortality after surgery |
| Postoperative lung function | at the 3rd month after surgery | forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre |
| 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 |
| 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 |
| Disease-free survival （DFS） | up to 60 months | Up to the date of disease recurrence since the date of randomization |
| Preoperative lung function | Baseline | forced expiratory volume at one second（FEV1） in litre, maximal voluntary ventilation （MVV） in litre |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total hospitalization expenditures | postoperative in-hospital stay up to 30 days | cost in hospital |
| Anatomical variations | During surgery | Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population |
Countries
China
Outcome results
None listed