UMIN-CTR Clinical Trial

Public 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

Acronym

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

Scientific 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

Scientific Title:Acronym

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

Early lung cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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]

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Kyoji HIrai

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Division of Thoracic Surgery

Zip code

Address

1715 Kamakari, Inzai, Chiba

TEL

0476-99-1111

Email

ky-hirai@nms.ac.jp

Name of contact person

1st name
Middle name
Last name	Kyoji Hirai

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Nippon Medical School Chiba Hokusoh Hospital

Zip code

Address

1715 Kamakari, Inzai, Chiba

TEL

0476-99-1111

Homepage URL

Email

ky-hirai@nms.ac.jp

Institute

Prince of Wales Hospital, Chinese University
of Hong Kong

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

None

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)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2017

Year

05

Month

01

Day

Date of IRB

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

Other related information

Registered date

2017

Year

11

Month

10

Day

Last modified on

2018

Year

12

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034095