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

NCT ID: NCT02992353

Last Updated: 2016-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 231 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-06-30

Brief 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.

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.

Conditions

Lung Neoplasm

Keywords

VATS; NSCLC; recurrence rate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Three-port pulmonary resection surgery

Intervention Type: PROCEDURE

Three-port pulmonary resection surgery

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.

Group Type: ACTIVE_COMPARATOR

Single-port or two-port surgery

Intervention Type: PROCEDURE

Single-port or two-port pulmonary resection surgery

Interventions

Three-port pulmonary resection surgery

Three-port pulmonary resection surgery

Intervention Type: PROCEDURE

Single-port or two-port surgery

Single-port or two-port pulmonary resection surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ju-Wei Mu

MD, PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juwei Mu, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Municipal Science & Technology Commission

Locations

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Juwei Mu, MD

Role: CONTACT

Phone: 8610-87788495

Email: mujuwei@cicams.ac.cn

Facility Contacts

Juwei Mu, MD

Role: primary

Other Identifiers

Z161100000116044

Identifier Type: -

Identifier Source: org_study_id