UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031848 |
|---|---|
| Receipt number | R000036367 |
| Scientific Title | peripheral marking with CT for Thoracoscopic surgery |
| Date of disclosure of the study information | 2018/03/22 |
| Last modified on | 2021/02/08 12:59:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
peripheral marking with CT for Thoracoscopic surgery
Acronym
Peripheral marking for TS
Scientific Title
peripheral marking with CT for Thoracoscopic surgery
Scientific Title:Acronym
Peripheral marking for TS
Region
| Japan |
Condition
Condition
Pulmonary Tumor
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Before surgery, peripheral marking is performed above the tumor using CT and whether or not marking on the visceral pleurum just above the tumor is examined during the subsequent surgery is examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Distance between the marking site on the lung surface and the actual center of the tumor.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
CT guide direct skin marking of the tumor
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
Primary lung cancer (bronchoscopic lung biopsy or intraoperative rapid test) or suspected
Metastatic lung tumor
Tumor size up to 2 cm. The distance from the lung surface is 2 cm or less.
Partial resection is planned. (As a result of pathological diagnosis, cases involving lung lobectomy are included)
20-85 years old
Indication of whole body condition: Performance Status (ECOG) 0 or 1
Related major organ function
Following a sufficient informed consent to participate in this study, the patient consent was obtained with the free will of the patient himself / herself
Key exclusion criteria
Patient who does not need to judge localization of tumor intraoperatively (patient planning to perform lobectomy from the beginning)
Case in which marking of the wall side pleura is expected to be difficult after marking the body surface, such as when there is a lesion on the back side of the shoulder blades or there is a lesion on the longitudinal side
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Sekimura |
Organization
Kanazawa Medical University
Division name
Thoracic Surgery
Zip code
920-0265
Address
Ishikawaken
TEL
0762862211
a2seki4@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Sekimura |
Organization
Kanazawa Medical University
Division name
Thoracic Surgery
Zip code
920-0265
Address
Ishikawaken
TEL
0762862211
Homepage URL
a2seki4@yahoo.co.jp
Sponsor or person
Institute
Kanazawa Medical University
Department of thoracic surgery
Institute
Department
Personal name
Funding Source
Organization
Kanazawa Medical University, Department of Thoracic Surgery
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa medical university
Address
1-1 Daigaku, Uchinadacho, Kahokugun
Tel
0762862211
tiken@kanazawa-med.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
金沢医科大学病院 呼吸器外科
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 22 | 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
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 22 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036367
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
