Phase II Study of Pleurodesis using Sterile Graded Talc in Patients with Secondary Intractable Pneumothorax: Protocol for a Multicentre, Open-label Single-arm Trial
Hiroshima Journal of Medical Sciences Volume 67 Issue 1
Page 15-20
published_at 2018-03
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| File | |
| Title ( eng ) |
Phase II Study of Pleurodesis using Sterile Graded Talc in Patients with Secondary Intractable Pneumothorax: Protocol for a Multicentre, Open-label Single-arm Trial
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| Creator |
Kitagawa Chiyoe
Saka Hideo
Kada Akiko
Saito Akiko M.
Takei Hidefumi
Matsutani Noriyuki
Takahashi Noriaki
Mineshita Masamichi
Kawano Osamu
Bessho Akihiro
Miyazawa Hideki
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| Source Title |
Hiroshima Journal of Medical Sciences
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| Volume | 67 |
| Issue | 1 |
| Start Page | 15 |
| End Page | 20 |
| Journal Identifire |
[PISSN] 0018-2052
[EISSN] 2433-7668
[NCID] AA00664312
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| Abstract |
A pneumothorax can be primary or secondary. A high proportion of patients with secondary spontaneous pneumothorax are the elderly who are in poor general condition due to their impaired cardiac and pulmonary functions as well as due to other complications. Therefore, it may be difficult for these patients to undergo surgical procedures; in addition, the elderly may be at high risk for postoperative pulmonary fistula due to severe adhesions and emphysema complications. These non-operative and high-risk cases may be treated with pleurodesis (a procedure that involves instillation of a chemical or irritant into the thoracic cavity through an injection), bronchoscopic bronchial embolisation, or other procedures. In Japan, no device is currently approved for performing pleurodesis, but an approval of one device is expected soon. This will be an open-label, single-arm multicentre study conducted among 30 patients with secondary intractable pneumothorax who are not indicated to undergo surgery. The primary endpoint will be presence or absence of chest tube removal. The secondary endpoints will be the disappearance/decrease of air leakage, grade of dyspnoea, and duration of drainage. This study will assess the safety and efficacy of sterile graded talc pleurodesis in patients with secondary intractable pneumothorax.
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| Keywords |
secondary pneumothorax
talc
pleurodesis
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| Descriptions |
This research is (partially) supported by the Project Promoting Clinical Trials for Development of New Drugs and Medical Devices (Japan Medical Association) and Early/Exploratory Clinical Trial Center Development Projects from the Japan Agency for Medical Research and Development (AMED).
This study is registered in the Center for Clinical Trials, Japan Medical Association (JMA-IIA00272). |
| NDC |
Medical sciences [ 490 ]
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| Language |
eng
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| Resource Type | departmental bulletin paper |
| Publisher |
Hiroshima University Medical Press
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| Date of Issued | 2018-03 |
| Rights |
Copyright (c) 2018 Hiroshima University Medical Press
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| Publish Type | Version of Record |
| Access Rights | open access |
| Source Identifier |
[ISSN] 0018-2052
[ISSN] 2433-7668
[NCID] AA00664312
[DOI] 10.24811/hjms.67.1_15
[DOI] https://doi.org/10.24811/hjms.67.1_15
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