Clinical trial NCT02992353: Single-port, Two-port Versus Three-port VATS on Non-small Cell Lung Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Neoplasm
Keywords: VATS
NSCLC
recurrence rate
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-12-14
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Local recurrence
timeFrame: 2 years
Secondary outcomes:
measure: Postoperative respiratory complications
timeFrame: 30 days after surgery
measure: Lymph node dissection
timeFrame: Intraoperation
measure: Blood loss
timeFrame: Intraoperation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital of Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Beijing Municipal Science & Technology Commission
name: Juwei Mu, MD
role: PRINCIPAL_INVESTIGATOR
References: