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 |
A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge
A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge
A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge
A Study of Stump formation of lobar bronchus closed by Endo GIA Tri-Staple or Endo GIA Roticulator cartridge
Japan |
Lung Cancer
Chest surgery |
Malignancy
NO
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).
Efficacy
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.)
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
60
1st name | |
Middle name | |
Last name | Masahiko Higashiyama |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Thoracic Surgery
1-3-3 Nakamichi, Higashinari-ku, Osaka-shi, 573-5811
1st name | |
Middle name | |
Last name | Jiro Okami |
Osaka Medical Center for Cancer and Cardiovascular Diseases
Department of Thoracic Surgery
1-3-3 Nakamichi, Higashinari-ku, Osaka-shi, 573-5811
Osaka Medical Center for Cancer and Cardiovascular Diseases
Covidien Japan Inc.
Profit organization
NO
2013 | Year | 01 | Month | 19 | Day |
Unpublished
Completed
2012 | Year | 09 | Month | 17 | Day |
2013 | Year | 01 | Month | 21 | Day |
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).
2013 | Year | 01 | Month | 19 | Day |
2018 | Year | 07 | Month | 25 | Day |
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 |