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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029906
Receipt No. R000034095
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
Date of disclosure of the study information 2018/01/11
Last modified on 2018/12/24

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Basic information
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
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
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

Public contact
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
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/ctr_e/ctr_view.cgi?recptno=R000034095

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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