3D reconstruction
Other3-dimensional computed tomography reconstruction guided VATS segmentectomy
NCT Number: NCT04004494
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Union Hospital of Fujian medical university, Fujian, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Exclusion criteria
3-dimensional computed tomography reconstruction guided VATS segmentectomy
Time frame: During surgery
the time of operation
Time frame: During surgery
Amount of intraoperative blood loss
Time frame: During surgery
the rate of conversion to open surgery in the operation
Time frame: During surgery
the accident event happened in operative. For example, a segmentectomy is converted to a lobectomy
Time frame: Postoperative in-hospital stay up to 30 days
mainly include: pneumonia, arrhythmia, incision infection, vocal cord paralysis, trachea cannula
Time frame: Up to 24 weeks
length of stay in hospitalization
Time frame: Up to 4 weeks
Duration of chest tube placement
Time frame: Postoperative in-hospital stay up to 30 days
30-day mortality after surgery
Time frame: 2 weeks after surgery
including overall lymph node count, number of stations dissected and number of lymph nodes in each lymph node station
Time frame: up to 60 months
Up to the date of death of any causes since the date of randomization
Time frame: up to 60 months
Up to the date of disease recurrence since the date of randomization
Time frame: Baseline
forced expiratory volume at one second(FEV1) in litre, maximal voluntary ventilation (MVV) in litre
Time frame: at the 3rd month after surgery
forced expiratory volume at one second(FEV1) in litre, maximal voluntary ventilation (MVV) in litre
Time frame: 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
Time frame: postoperative in-hospital stay up to 30 days
cost in hospital
Time frame: During surgery
Rate of anatomical variation of segmental bronchus and pulmonary vessel in Chinese population
Ruijin Hospital
Other
Three-dimensional Computed Tomography Reconstruction for Operative Planning in VATS Segmentectomy
Acronym: DRIVATS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06132607
Humans, Lobectomy
Heerlen, Limburg, Netherlands
View Trial DetailsNCT05350137
Lung Cancer, Lung Diseases
Wuhan, Hubei, China
View Trial DetailsNCT05453721
Bronchial Neoplasms, Carcinoma, Bronchogenic
Nanchang, Jiangxi, China
View Trial DetailsNCT01775657
Lobectomy, Pulmonary Air Leak
Ottawa, Ontario, Canada
View Trial Details