Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Union hospital of Fujian Medical University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D Reconstruction | Experimental | 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. |
|
| Chest computed tomography | No Intervention | Chest contrast-enhanced computed tomography will be performed preoperatively. Video-assisted segmentectomy will be performed based on the image of preoperative chest CT |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D reconstruction | Other | 3-dimensional computed tomography reconstruction guided VATS segmentectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| operative time | the time of operation | During surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total hospitalization expenditures | cost in hospital | postoperative in-hospital stay up to 30 days |
| Anatomical variations | Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population |
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| He-Cheng Li, doctor | Ruijin Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital of Fujian medical university | Fujian | Fujian | 350001 | China | ||
| Guangdong General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36311929 | Derived | Niu Z, Chen K, Jin R, Zheng B, Gong X, Nie Q, Jiang B, Zhong W, Chen C, Li H. Three-dimensional computed tomography reconstruction in video-assisted thoracoscopic segmentectomy (DRIVATS): A prospective, multicenter randomized controlled trial. Front Surg. 2022 Oct 13;9:941582. doi: 10.3389/fsurg.2022.941582. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Parallel Assignment
Not provided
Not provided
Not provided
Not provided
| 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 |
| During surgery |
| Guangdong |
| Guangdong |
| 510080 |
| China |
| Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |