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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasm
• Intervention / Treatment: Procedure: Three-port pulmonary resection surgery; Procedure: Single-port or two-port surgery

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 231
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 110000
      • Recruiting
      • Cancer Hospital of Chinese Academy of Medical Sciences
      • Contact: Juwei Mu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Three-port pulmonary resection surgery; 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; Three-port pulmonary resection surgery
Active Comparator: Single-port or two-port 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; Single-port or two-port pulmonary resection surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence	two-year local recurrence rate after surgery	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss	blood loss during the surgery	Intraoperation
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
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Juwei Mu, MD, Beijing Municipal Science & Technology Commission

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 14, 2016

Study Record Updates

• Last Update Posted (Estimate): December 14, 2016
• Last Update Submitted That Met QC Criteria: December 12, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: NSCLC; VATS; recurrence rate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Z161100000116044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED