Single-port, Two-port Versus Three-port VATS on Non-small Cell Lung Cancer

Lung Neoplasm Clinical Trial

Official title:

Single-port Versus Two-port Versus Three-port Video Assisted Thoracoscopic Pulmonary Resection on Non-small Cell Lung Cancer: a Prospective Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02992353
• Other study ID #: Z161100000116044
• Status: Recruiting
• Phase: N/A
• First received: December 12, 2016
• Last updated: December 12, 2016
• Start date: July 2016
• Est. completion date: June 2019

Study information

• Verified date: December 2016
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Juwei Mu, MD
• Phone: 8610-87788495
• Email: mujuwei[@]cicams.ac.cn
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 231
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age between 18 and 80 years;

• cT1-3N0-1M0 diagnosed by chest CT or PET-CT before operation;

• ECOG PS scores=2;

• The patients sign informed consents by themselves.

Exclusion Criteria:

• Inability to tolerance of tracheal intubation and general anesthesia;

• ECOG PS scores>2;

• Severe comorbidities including: Angina occurs in 3 months, uncontrolled hypertension, Congestive heart failure, a history of myocardial infarction in 6 months before admission, severe arrhythmia, severe liver, kidney or other metabolic diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasm
• Lung Neoplasms

Intervention

Procedure:
• Three-port pulmonary resection surgery
Three-port pulmonary resection surgery
• Single-port or two-port surgery
Single-port or two-port pulmonary resection surgery

Locations

Country	Name	City	State
China	Cancer Hospital of Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local recurrence	two-year local recurrence rate after surgery	2 years	Yes
Secondary	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.	30 days after surgery	Yes
Secondary	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.	Intraoperation	Yes
Secondary	Blood loss	blood loss during the surgery	Intraoperation	Yes