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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Lung Neoplasm

Treatments: Procedure: Three-port pulmonary resection surgery; Procedure: Single-port or two-port surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02992353

Z161100000116044

Details and patient eligibility

About

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.

Full 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.

Enrollment: 231 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

231 participants in 2 patient groups

Three-port pulmonary resection surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Three-port pulmonary resection surgery

Single-port or two-port surgery

Active Comparator group

Description:

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.

Treatment:

Procedure: Single-port or two-port surgery