UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-port versus conventional three-port video-assisted thoracic surgery (VATS) for early-stage NSCLC: short- and long-term outcomes of a multicentre randomised trial
Title of the study (Brief title)	Single-port versus conventional three-port video-assisted thoracic surgery (VATS) for early-stage NSCLC: short- and long-term outcomes of a multicentre randomised trial
Region	Japan Asia(except Japan)

Condition
Condition	Early lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study and compare the long-term results on survival and cancer recurrence between multi-port thoracoscopic and single-port thoracoscopic surgery in treating early-stage non-small cell lung cancer. In addition, perioperative functional and physiological changes, number of lymph nodes dissected, and postoperative pain between the two thoracoscopic approaches will be investigated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	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);
Key secondary outcomes	* 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]

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	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 or 5th intercostal space without rib spreading between the anterior and posterior axillary line and the auxiliary port in the same intercostal space adjacent to the scapula posteriorly will be created as well. Rib spreader is not recommend when technically feasible. A 24F chest tube will be placed at the camera port for drainage.
Interventions/Control_2	Single-port VATS group (trial arm): a single incision of 3 to 5 cm without rib spreading will be performed at the 4th or 5th intercostal space positioned between the anterior and posterior axillary line. Whenever conversion to two-port VATS is necessary, a midaxillary 12-mm port is placed in the seventh or eighth intercostal space. Of note, a rib spreader is not recommend when technically feasible. A 24F chest tube will be placed and secured towards one end of the single incision.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	Kyoji HIrai
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Thoracic Surgery
Address	1715 Kamakari, Inzai, Chiba
TEL	0476-99-1111
Email	ky-hirai@nms.ac.jp

Public contact
Name of contact person	Kyoji Hirai
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Nippon Medical School Chiba Hokusoh Hospital
Address	1715 Kamakari, Inzai, Chiba
TEL	0476-99-1111
Homepage URL
Email	ky-hirai@nms.ac.jp

Sponsor
Institute	Prince of Wales Hospital, Chinese University of Hong Kong
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	Nippon Medical School Chiba Hokusoh Hospital Guro Hospital, University of Korea Koo Foundation Sun Yat-Sen Cancer Center
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 11 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2022 Year 01 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 10 Day
Last modified on	2018 Year 12 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034095