Unique ID issued by UMIN | UMIN000031104 |
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Receipt number | R000035522 |
Scientific Title | Efficacy and safety of Picibanil (OK-432) for pleurodesis in refractory pneumothorax and postoperative lung fistula |
Date of disclosure of the study information | 2018/02/01 |
Last modified on | 2018/08/17 16:14:00 |
Efficacy and safety of Picibanil (OK-432) for pleurodesis in refractory pneumothorax and postoperative lung fistula
Picibanil for pleurodesis in refractory pneumothorax and postoperative lung fistula
Efficacy and safety of Picibanil (OK-432) for pleurodesis in refractory pneumothorax and postoperative lung fistula
Picibanil for pleurodesis in refractory pneumothorax and postoperative lung fistula
Japan |
Refractory pneumothorax and postoperative lung fistula
Pneumology | Chest surgery |
Others
NO
To clarify the efficacy and safety of pleurodesis with Picibanil in patients with lung fistula (refractory pneumothorax or postoperative lung fistula). Assessment of lung fistula, drainage period, hospitalization period, and adverse events.
Safety,Efficacy
Ratio of lung fistula that cured without surgical intervention
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Intrapleural injection of Picibanil once a day. A total of 1-20 KE of Picibanil can be injected within a period of 14 days if there is residual lung fistula.
Not applicable |
Not applicable |
Male and Female
1) patient with refractory pneumothorax or postoperative lung fistula
2) patient with intrathoracic drain
3) hospitalized patient
4) patient with written consent
1) patient with past history of allergy to Picibanil or penicillin-based antibiotic
2) patient that were judged unsuitable by the treating doctor
150
1st name | |
Middle name | |
Last name | Takashi Ibe |
Gunma University Hospital
Division of General Thoracic Surgery
3-39-15 Showa-machi, Maebashi-shi, Gunma-ken
027-220-8224
t-ibe@gunma-u.ac.jp
1st name | |
Middle name | |
Last name | Takashi Ibe |
Gunma University Hospital
Division of General Thoracic Surgery
3-39-15 Showa-machi, Maebashi-shi, Gunma-ken
027-220-8224
t-ibe@gunma-u.ac.jp
Gunma University
Gunma University
Other
NO
2018 | Year | 02 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2018 | Year | 02 | Month | 01 | Day |
2018 | Year | 02 | Month | 01 | Day |
2018 | Year | 02 | Month | 01 | Day |
2018 | Year | 08 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035522
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