UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037661
Receipt number R000042949
Scientific Title Thoracoscopic pulmonary nodule localization using CT guided pleural marking
Date of disclosure of the study information 2019/11/01
Last modified on 2021/02/08 13:00:21

* 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

Thoracoscopic pulmonary nodule localization using CT guided pleural marking

Acronym

Pleural marking with CT image

Scientific Title

Thoracoscopic pulmonary nodule localization using CT guided pleural marking

Scientific Title:Acronym

Pleural marking with CT image

Region

Japan


Condition

Condition

pulmonary tumor

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of accuracy of the pleural marking procedure using preoperative CT.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Distance between Marking and pleula near by Tumor

Key secondary outcomes

Cut line margin


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment Maneuver

Interventions/Control_1

Pleural marking using preoperative CT image

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

pulmonary 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 is expected to be difficult.

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

Department of Thoracic Surgery

Zip code

9200265

Address

1-1 Daigaku, Uchinadacho, Kahokugun, Ishikawaken

TEL

0762862211

Email

a2seki4@yahoo.co.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Sekimura

Organization

Kanazawa Medical University

Division name

Department of thoracic surgery

Zip code

9200265

Address

1-1 Daigaku, Uchinadacho, Kahokugun, Ishikawaken

TEL

0762862211

Homepage URL


Email

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, Ishikawaken

Tel

0762862211

Email

a2seki4@yahoo.co.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(石川県)


Other administrative information

Date of disclosure of the study information

2019 Year 11 Month 01 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

2019 Year 04 Month 01 Day

Date of IRB

2019 Year 04 Month 22 Day

Anticipated trial start date

2019 Year 04 Month 23 Day

Last follow-up date

2020 Year 02 Month 29 Day

Date of closure to data entry

2020 Year 02 Month 29 Day

Date trial data considered complete

2020 Year 02 Month 29 Day

Date analysis concluded

2020 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 08 Month 10 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=R000042949


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name