UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030388 |
|---|---|
| Receipt number | 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 11:46:09 |
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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
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
kihutisk826@yahoo.co.jp
Sponsor or person
Institute
General Thoracic Surgery, Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034691
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