Early lung cancer
Conditions
Interventions
Conventional VATS group (control arm): A 12-mm incision in the 6-8th intercostal space on the anterior axillary line will be created for camera placement, the utility incision of 3 to 5 cm in the 4th
Sponsors
Prince of Wales Hospital, Chinese University of Hong Kong
Nippon Medical School Chiba Hokusoh Hospital Guro Hospital, University of Korea Koo Foundation Sun Yat-Sen Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages eligible for study: 18-75 years Patient with pulmonary lesion susceptive of early-stage (I/II according to the UICC Staging System TNM classification for NSCLC, 7th version) malignancy that is suitable for VATS Technically feasible for both single-port or multiport approaches in the opinion of the recruiting surgeon ASA (American Society of Anaesthesiologists) score 1, 2 or 3 that will be suitable underwent general anaesthesia
Exclusion criteria
Exclusion criteria: Refuse/incapable to provide a written consent Re-do surgery Preoperative evidence of extensive pleural symphysis Previous history of chemotherapy or thoracic radiotherapy Inadequate cardiopulmonary function for lobectomy Contraindications to general anaesthesia/VATS: unable to tolerate one-lung ventilation, coagulopathy Pregnant/lactating female patients History of other malignancies in past 5 years (except for non-melanoma skin cancer, cervix cancer in situ, early-stage prostate cancer) Previous history of pulmonary resection Diseases associated with chest pain such as coronary artery disease, herpes zoster etc. Patients requiring resection of lung that is more than a lobectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) at 3 years, defined as the time interval from randomisation to the earliest onset of any of the following events at 3 years: tumour recurrence, metastasis. Patients who survived past the last follow-up scheme without the above situations will be classified as censored cases (disease-free at the end of follow-up); Overall survival (OS) at 3 years, defined as the time interval from randomisation to the death caused by any reason at 3 years. Patients who survived past the last follow-up scheme will be classified as censored cases (alive at the end of follow-up); | — |
Secondary
| Measure | Time frame |
|---|---|
| * Mean Visual Analogue Scale (VAS) pain score at 24 hours [Time Frame: At 24 hours after surgery] VAS pain score; 0 = no pain, 10 = worst pain participant could imagine * Maximum postoperative VAS pain score [Time frame: before discharge] * Mean VAS pain score of postoperative day one, three, five and seven [Time frame: 24 hours, 3, 5 and 7 days post-surgery] *Mean VAS pain score of postoperative day seven (if patient has not been discharged already) [Time frame: 7 days post-surgery] *Total post-operative morphine consumption (mg) [Time frame: in the first 24 hours postoperatively] * Conversion from single to multiport [Time frame: during surgery] Proportion of the trial arm (single port) converted to multiple port VATS or open thoracotomy after randomization * Mortality [Time frame: 30 days postoperatively] *Complications [Time frame: during and post-surgery during hospital stay] *ICU admission [Time frame: after surgery and before discharge (expected to be within 48 hours)] * Hospital readmission rate [Time frame: within 30 days of surgery] *Readmission for any complication of the thoracic surgery *Pulmonary function test: Pre-operative forced expiratory volume in 1 sec (FEV1) , Diffusing lung capacity for carbon monoxide (DLCO) and at post-operative 4 weeks. [Time frame: pre-operative and 4 weeks postoperatively] *Change in Quality of Life (QoL) score [Time Frame: Performed pre-operatively and every 6 months in the 3 years after] | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactKyoji Hirai
Nippon Medical School Chiba Hokusoh Hospital Nippon Medical School Chiba Hokusoh Hospital
Outcome results
None listed