UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of lung segmentectomy for intraoperative selective intra-bronchial air supply catheter
Acronym	Lung segmentectomy by intora-bronchial air supply catheter
Scientific Title	Evaluation of lung segmentectomy for intraoperative selective intra-bronchial air supply catheter
Scientific Title:Acronym	Lung segmentectomy by intora-bronchial air supply catheter
Region	Japan

Condition
Condition	Lung tumor
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	1) Evaluation of intraoperative use of intratracheal air supply catheter 2) Homogenization of procedures in lung segmentectomy and confirmation of reproducibility
Basic objectives2	Others
Basic objectives -Others	Research on surgery and procedures
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Completion rate of lung segmentectomy
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Use of air supply catheter in lung segmentectomy
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Primary lung cancer, metastatic lung tumor, benign tumor patients who can undergo lung segmentectomy under general anesthesia. 2.Patients with normal lung function 3.Patients with interstitial pneumonia 4.Patients with Pulmonary emphysema >2 degrees in Gold classification 5.Patients of age 20 years or older 6.Patients who gave sufficient consultation on participation of this study and obtained consent
Key exclusion criteria	1.History of Allergy to Material 2.Bronchial traveling abnormality 3.Dementia and disturbance of consciousness 4.Cases judged inappropriate by a doctor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Kobayashi Masashi
Organization	Tokyo medical and Dental University
Division name	Department of Thoracic Surgery
Zip code	113-8519
Address	1-5-45 Yushima, Bukyo-ku, Tokyo
TEL	03-5803-4072
Email	mkobthsr@tmd.ac.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Kobayashi
Organization	Tokyo medical and Dental University
Division name	Department of Thoracic Surgery
Zip code	113-8519
Address	1-5-45 Yushima, Bukyo-ku, Tokyo
TEL	03-5803-4072
Homepage URL
Email	mkobthsr@tmd.ac.jp

Sponsor
Institute	Tokyo medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo medical and Dental University
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	Tokyo medical and Dental University
Address	1-5-45 Yushima, Bukyo-ku, Tokyo
Tel	03-5803-5096
Email	mkan-rinsho.adm@tmd.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	2018 Year 09 Month 30 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	Open public recruiting
Date of protocol fixation	2018 Year 09 Month 15 Day
Date of IRB	2018 Year 09 Month 21 Day
Anticipated trial start date	2018 Year 09 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry	2022 Year 09 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 15 Day
Last modified on	2021 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038950