UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043969
Receipt number R000050030
Scientific Title Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy
Date of disclosure of the study information 2021/04/19
Last modified on 2023/10/22 12:44:34

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Basic information

Public title

Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy

Acronym

Prospective observational study about tissue thickness of bronchus in lung surgery

Scientific Title

Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy

Scientific Title:Acronym

Prospective observational study on tissue thickness and staple formation of bronchial stump in lobectomy

Region

Japan


Condition

Condition

Primary lung cancer
Metastatic lung tumor

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To correct data that will be helpful to establish criteria for the selection of suitable cartridges for bronchial suturing and development of automatic staplers by evaluating the tissue thickness of the lobar bronchial wall and the staple formation of the staple cartridges selected.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between bronchial wall thickness, staple cartridge type, and staple formation

Key secondary outcomes

Correlation between bronchial wall thickness, gender, age, body size, smoking history, and underlying diseases

Correlation between bronchial wall thickness based on CT findings and actual measurement


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients scheduled for resection of the lower lobe of the right or left lung for primary lung cancer or metastatic lung tumor (including suspected) in our department.

Key exclusion criteria

Patients with central localization or extension of the tumor that makes it difficult to suture the bronchus with an automatic suture in the normal line of dissection.

Patients who have undergone any preoperative treatment.

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Masayuki
Middle name
Last name Nakao

Organization

Cancer Institute Hospital, The Japanese Foundation for Cancer Research

Division name

Department of Thoracic Surgical Oncology

Zip code

135-8550

Address

3-10-6 Ariake, Koto-ku, Tokyo, Japan

TEL

03-3520-0111

Email

masayuki.nakao@jfcr.or.jp


Public contact

Name of contact person

1st name Masayuki
Middle name
Last name Nakao

Organization

Cancer Institute Hospital, The Japanese Foundation for Cancer Research

Division name

Department of Thoracic Surgical Oncology

Zip code

135-8550

Address

3-10-6 Ariake, Koto-ku, Tokyo, Japan

TEL

03-3520-0111

Homepage URL


Email

masayuki.nakao@jfcr.or.jp


Sponsor or person

Institute

Cancer Institute Hospital, The Japanese Foundation for Cancer Research

Institute

Department

Personal name



Funding Source

Organization

Johnson & Johnson K.K. Medical Company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Cancer Institute Hospital, The Japanese Foundation for Cancer Research

Address

3-10-6 Ariake, Koto-ku, Tokyo, Japan

Tel

03-3520-0111

Email

med.shinsa@jfcr.or.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

がん研究会有明病院(東京都)


Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 19 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

No longer recruiting

Date of protocol fixation

2020 Year 10 Month 20 Day

Date of IRB

2020 Year 12 Month 22 Day

Anticipated trial start date

2021 Year 04 Month 19 Day

Last follow-up date

2023 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation items:

Correlation between bronchial wall thickness, staple cartridge type, and staple formation

Correlation between bronchial wall thickness, gender, age, body size, smoking history, and underlying diseases

Correlation between bronchial wall thickness based on CT findings and actual measurement


Management information

Registered date

2021 Year 04 Month 19 Day

Last modified on

2023 Year 10 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050030


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name