UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Acronym	Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Scientific Title	Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Scientific Title:Acronym	Investigation of short-term and long-term prognosis of robot-assisted surgery for pulmonary malignancy
Region	Japan

Condition
Condition	pulmonary malignancy
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze the short- and long-term postoperative outcomes of robot-assisted surgery in respiratory surgery and to establish the utility and safety of robot-assisted surgery in respiratory surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Incidence of postoperative complications
Key secondary outcomes	Robotic surgery completion rate, intraoperative blood loss, operative time, length of hospital stay, medical costs, recurrence-free survival and overall survival

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Robotic-assisted surgery is performed using the da Vinci Surgical System x, and the target procedure is "thoracoscopic pulmonary malignancy surgery (resection of the lung lobes or more than one lung lobe with endoscopic surgical support equipment). It is. The treatment and diagnostic policies and the extent of lymph node dissection for lung cancer are in accordance with the 2018 edition of the Lung Cancer Practice Guidelines.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	PS (Performance Status) is 0 or 1. No prior treatment for the disease. Consent to participate in the study has been obtained in writing. Diagnosis of pulmonary malignancy has been obtained by preoperative imaging or pathological examination. In the case of primary lung malignancy, preoperative imaging indicates that the clinical stage of lung cancer is stage I-II. In the case of metastatic pulmonary malignancy, no metastasis is observed in organs other than the lung.
Key exclusion criteria	PS (Performance Status) is 0 or 1. No prior treatment for the disease. Consent to participate in the study has been obtained in writing. Diagnosis of pulmonary malignancy has been obtained by preoperative imaging or pathological examination. In the case of primary lung malignancy, preoperative imaging indicates that the clinical stage of lung cancer is stage I-II. In the case of metastatic pulmonary malignancy, no metastasis is observed in organs other than the lung.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name HIDEKI Middle name Last name MATSUDAIRA
Organization	The Jikei University School of Medicine
Division name	The Division of Thoracic Surgery, the Department of Surgery
Zip code	105-8461
Address	University Hall 2, 3-25-8, Nishi-Shimbashi, Minato-ku
TEL	0334331111
Email	hideki.matsudaira@gmail.com

Public contact
Name of contact person	1st name HIDEKI Middle name Last name MATSUDAIRA
Organization	The Jikei University School of Medicine
Division name	The Division of Thoracic Surgery, the Department of Surgery
Zip code	105-8461
Address	University Hall 2, 3-25-8, Nishi-Shimbashi, Minato-ku
TEL	0334331111
Homepage URL
Email	hideki.matsudaira@gmail.com

Sponsor
Institute	he Division of Thoracic Surgery, the Department of Surgery, the Jikei University School of Medicine
Institute
Department

Funding Source
Organization	The Division of Thoracic Surgery, the Department of Surgery, the Jikei University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Jikei University School of Medicine
Address	3-25-8, Nishi-Shimbashi, Minato-ku
Tel	0334331111
Email	rinri@jikei.ac.jp

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	2020 Year 04 Month 14 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	Enrolling by invitation
Date of protocol fixation	2020 Year 02 Month 03 Day
Date of IRB	2020 Year 02 Month 03 Day
Anticipated trial start date	2020 Year 04 Month 14 Day
Last follow-up date	2025 Year 04 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 04 Month 01 Day
Last modified on	2020 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045626