An interventional study of Three-port pulmonary resection surgery and Single-port or two-port surgery in Lung Neoplasm, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-12-14.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Not applicable, Interventional, and Treatment
In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and 39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is performed in clinical operation with the aim of decreasing postoperative complications morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised controlled trial regarding Single-port versus two-port versus three-port video assisted thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and two-port VATS were feasible and safe through the trial, and we hope the results of our study will provide a high level of clinical evidence for choosing the best operative approach in VATS.
Introduction: In china, the incidence and death rate of lung cancer is 48.32 per 100 000 person-years and 39.27 per 100 000 person-years, respectively, the highest in malignant tumor. Surgical operation is still main treatment means to resectable NSCLC. VATS pulmonary resection is performed in clinical operation with the aim of decreasing postoperative complications morbidity. The mechanisms may be due to minimize the inflammation reaction to surgical injury. There are some trials regarding two-port VATS versus three-port VATS versus four-port VATS or single-port VATS versus three-port VATS. However, there is no prospective randomised controlled trial regarding Single-port versus two-port versus three-port video assisted thoracoscopic pulmonary resection on NSCLC. So, we hope to demonstrate that single-port and two-port VATS were feasible and safe through the trial, and we hope the results of our study will provide a high level of clinical evidence for choosing the best operative approach in VATS.
Methods and analysis: this is a three years prospective randomised controlled trial, which aims to attest the safety and feasibility of simple-port VATS and two-port VATS. Group A, B and C receives single-port VATS, two-port VATS and three-port VATS pulmonary resection respectively. The primary endpoint is postoperative recurrence rate. The secondary endpoints include other postoperative complications morbidity , such as the number and location of lymph nodes dissected、operation time, intraoperative volume of blood loss, hospital stays, hospitalization expenses, quantity of using antalgica, change of pulmonary function. 70 patients are enrolled per group in three years, after adding 10% loss of the sample, 77 patients will be required for each group so a total of 231 patients will be enrolled into the study in the end.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 231 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
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Exclusion Criteria:
Treated by traditional video assisted thoracoscopic three-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.
Procedure: Three-port pulmonary resection surgery
Treated by minimally invasive video assisted thoracoscopic single-port or two-port pulmonary resection in the centers with enough experience in VATS and the volume ≧50 cases each year.
Procedure: Single-port or two-port surgery
Three-port pulmonary resection surgery
Single-port or two-port pulmonary resection surgery
Local recurrence
two-year local recurrence rate after surgery
Time frame: 2 years
Postoperative respiratory complications
Systematic Classification of Morbidity and Mortality After Thoracic Surgery. Grade I, any complication without need for pharmacologic treatment or other intervention. Grade II, any complication that requires pharmacologic treatment or minor intervention only. Grade III , any complication that requires surgical, radiologic, endoscopic intervention, or multitherapy. Grade IV, any complication requiring intensive care unit management and life support. Grade V, any complication leading to the death of the patient.
Time frame: 30 days after surgery
Lymph node dissection
During the surgery, lymph node dissection were performed. The number of removed lymph-nodes were recorded according to the postoperative pathological diagnosis, and the stations of the lymph node were recorded according to the International Association for the Study of Lung Cancer (IASLC) Lymph Node Map.
Time frame: Intraoperation
Blood loss
blood loss during the surgery
Time frame: Intraoperation
Plan to share: Undecided
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This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences