UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009813
Receipt number R000011495
Scientific Title A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge
Date of disclosure of the study information 2013/01/19
Last modified on 2018/07/25 09:10:15

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Basic information

Public title

A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge

Acronym

A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge

Scientific Title

A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge

Scientific Title:Acronym

A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge

Region

Japan


Condition

Condition

Lung Cancer

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the performance of stapling and effect on the tissue at the lobar bronchus stump using the two different stapler cartridges (Endo GIA Tri-Staple and Endo GIA Roticulator).

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Performance of stapling at the bronchial stump of resected tissue (staple formation and alignment, dehiscence, etc.) in lobectomy using the staplers, and the histopathological evaluation (tissue inflammation, bleeding, other reactions, etc.)

Key secondary outcomes



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

1)Patients scheduled to undergo bronchial resection with an linear stapler (Endo GIA Tri-Staple or Endo GIA
2)Patients aged 20 years or older
3)Patients scheduled for lobectomy
4)Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) of either 0 or 1
5)Patients with healthy organ function
6)Patients who have provided written informed consent to participate in the study

Key exclusion criteria

1)Patients who is scheduled right middle lobectomy or suspected invasion or progression of tumors in the lobar bronchi
2) Patients with active bacterial infection or fungal infection
3) Patients receiving continuous systemic administration (oral or intravenous) of steroids
4)Patients with uncontrolled diabetes mellitus (HbA1C>8.0)
5) Any others judged to be ineligible for the study by the investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiko Higashiyama

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Thoracic Surgery

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka-shi, 573-5811

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Jiro Okami

Organization

Osaka Medical Center for Cancer and Cardiovascular Diseases

Division name

Department of Thoracic Surgery

Zip code


Address

1-3-3 Nakamichi, Higashinari-ku, Osaka-shi, 573-5811

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka Medical Center for Cancer and Cardiovascular Diseases

Institute

Department

Personal name



Funding Source

Organization

Covidien Japan Inc.

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


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2013 Year 01 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

Completed

Date of protocol fixation

2012 Year 09 Month 17 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate the performance of stapling and effect on the tissue at the lobar bronchus stump using the two different stapler cartridges (Endo GIA Tri-Staple and Endo GIA Roticulator).


Management information

Registered date

2013 Year 01 Month 19 Day

Last modified on

2018 Year 07 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011495


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name