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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030388
Receipt No. R000034691
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
Date of disclosure of the study information 2017/12/14
Last modified on 2019/03/28

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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
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
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

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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