UMIN-CTR Clinical Trial

Basic information
Public title	A Phase 2 clinical trial to evaluate the safety and efficacy of cone beam CT guided video assisted thoracoscopic partial resection for impalpable small pulmonary nodules
Acronym	Cone beam CT guided video assisted thoracoscopic partial resection for impalpable small pulmonary nodules
Scientific Title	A Phase 2 clinical trial to evaluate the safety and efficacy of cone beam CT guided video assisted thoracoscopic partial resection for impalpable small pulmonary nodules
Scientific Title:Acronym	Cone beam CT guided video assisted thoracoscopic partial resection for impalpable small pulmonary nodules
Region	Japan

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

Objectives
Narrative objectives1	It is often difficult to detect impalpable small pulmonary nodules in video assisted thoracoscopic partial resection, which causes to extra normal lung resection or incomplete resection. The aim of this study is to evaluate the safety and efficacy of cone beam CT guided video assisted thoracoscopic partial resection for impalpable small pulmonary nodules.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	macroscopic complete resection rate
Key secondary outcomes	visualization rate, operating time, cone beam CT imaging time, microscopic complete resection rate, adverse events, the number of cone beam CT scanning, exposure of radiation

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	cone beam CT (2017. 11.15-2019.11.15)
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. Patients eligible for video assisted thoracoscopic partial resection for pulmonary malignancy or suspected lesions which is expected to be difficult to detect during operation (GGO-dominant (>50%) tumor with a diameter of 3cm or lower, or tumor with a diameter of 2cm or lower, which is located deeper than the diameter of the tumor from visceral pleura) 2. Between 20 years and 85 years 3. ECOG performance status 0-1 4. No definitive organd dysfuntion 5. Written consent obtaiend for this study
Key exclusion criteria	1. Pacemaker implantation 2. Cognitive impairment 3. Pregnancy or breast-feeding
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Ichiro Middle name Last name Yoshino
Organization	Chiba University Hospital
Division name	General Thoracic Surgery
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba, Chiba
TEL	0432227171
Email	iyoshino@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Taisuke Middle name Last name Kaiho
Organization	Chiba University Hospital
Division name	General Thoracic Surgery
Zip code	260-8670
Address	1-8-1, Inohana, Chuo-ku, Chiba, Chiba
TEL	0432227171
Homepage URL
Email	kihutisk826@yahoo.co.jp

Sponsor
Institute	General Thoracic Surgery, Chiba University Hospital
Institute
Department

Funding Source
Organization	General Thoracic Surgery, Chiba University Hospital
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	Chiba University Hospital Clinical Research Ethics Review Committee
Address	1-8-1, Inohana, Chuo-ku, Chiba, Chiba
Tel	043-222-7171
Email	prc-jim@chiba-u.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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 12 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	20
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	Completed
Date of protocol fixation	2017 Year 11 Month 15 Day
Date of IRB	2017 Year 11 Month 15 Day
Anticipated trial start date	2017 Year 12 Month 14 Day
Last follow-up date	2018 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2019 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date	2017 Year 12 Month 13 Day
Last modified on	2019 Year 03 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034691