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| ID | Type | Description | Link |
|---|---|---|---|
| 201402024007 | Other Grant/Funding Number | 201402024 |
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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Second Affiliated Hospital of Third Military Medical University | OTHER |
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The purpose of this study is to determine whether injecting autologous blood or putting bronchial plug through bronchoscope is effective in the treatment of refractory pneumothorax.
This is a multi-site, controlled, randomized study. Refractory pneumothorax is a challenge for respiratory physicians. Many patients present recurrent pneumothorax. Thoracic closed drainage is a basic and effective treatment to pneumothorax. Chronic obstructive pulmonary disease(COPD)is one of the main causes of spontaneous pneumothorax. Many patients precluded the performance of surgery for poor pulmonary function. In China, economical load is another reason for patients who are unwilling to surgery. So we want to seek a cheap, effective and safe method for refractory pneumothorax. We will adopt three methods in this study. Conventional thoracic closed drainage was continuously used in the control group, autologous blood was perfused to the target pulmonary segment in the treatment A group and self-made silicone bronchial plug was placed to the target pulmonary segment in the treatment B group. The leak position was detected by biliary lithotomy balloon. Main outcome measures: duration of continuous leakage. Secondary end-points included the lung reexpanded, hospital costs and hospital stays etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous blood group A | Experimental | Autologous blood was perfused to the target pulmonary segment |
|
| Bronchial plug group B | Experimental | Bronchial plug was placed to the target pulmonary segment |
|
| control group | No Intervention | Control group was given to continuous negative pressure drainage |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous blood | Other | Autologous blood was perfused to the target pulmonary segment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of air leakage | up to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| duration of pulmonary atelectasis | up to two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial blood gas | participants will be followed for the duration of hospital stay, an expected average of 4 weeks | |
| complications | Complications refers to the complications related to bronchoscopy treatment(include hemoptysis, short of breath, chest pain, fever ) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wangping Li, MD | Contact | 8618066620066; 8629-778526 | qxd25@163.com | |
| Yun Li, MD | Contact | 8618629675387 | littleyun@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Faguang Jin, MD & PhD | Tang-Du Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital | Recruiting | Xi'an | Shaanxi | 710038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25336533 | Background | Gilbert CR, Toth JW, Osman U, Reed MF. Endobronchial valve placement as destination therapy for recurrent pneumothorax in the setting of advanced malignancy. Respir Care. 2015 Mar;60(3):e46-8. doi: 10.4187/respcare.03540. Epub 2014 Oct 21. | |
| 24528320 | Background | Cundiff WB, McCormack FX, Wikenheiser-Brokamp K, Starnes S, Kotloff R, Benzaquen S. Successful management of a chronic, refractory bronchopleural fistula with endobronchial valves followed by talc pleurodesis. Am J Respir Crit Care Med. 2014 Feb 15;189(4):490-1. doi: 10.1164/rccm.201311-1965LE. No abstract available. |
| Label | URL |
|---|---|
| Click here for more information about this study: different treatment methods for different causes of pneumothorax | View source |
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| ID | Term |
|---|---|
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001804 | Blood Transfusion, Autologous |
| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| China Meitan General Hospital |
| OTHER |
| Micro-Tech (Nanjing) Co., Ltd. | INDUSTRY |
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| Bronchial plug | Device | Bronchial plug was placed to the target pulmonary segment |
|
| participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| hospital costs | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| Duration of hospital stays | participants will be followed for the duration of hospital stay, an expected average of 4 weeks |
| 23917049 | Background | Yamashita T, Urabe N. [Prolonged iatrogenic pneumothorax with refractory hepatic hydrothorax treated successfully with local anesthetic thoracoscopic talc poudrage]. Kyobu Geka. 2013 Jun;66(6):460-3. Japanese. |
| 23107020 | Background | Odaka M, Akiba T, Mori S, Asano H, Yamashita M, Kamiya N, Morikawa T. Thoracoscopic surgery for refractory cases of secondary spontaneous pneumothorax. Asian J Endosc Surg. 2013 May;6(2):104-9. doi: 10.1111/j.1758-5910.2012.00161.x. Epub 2012 Oct 29. |
| 22864128 | Background | Iyama S, Sato T, Murase K, Kikuchi S, Kamihara Y, Ono K, Takada K, Miyanishi K, Sato Y, Takimoto R, Kobune M, Obama T, Miyajima M, Watanabe A, Higami T, Hirayama Y, Kato J. Successful treatment by fibrin glue sealant for pneumothorax with chronic GVHD resistant to autologous blood patch pleurodesis. Intern Med. 2012;51(15):2011-4. doi: 10.2169/internalmedicine.51.7355. Epub 2012 Aug 1. |
| 22394587 | Background | Lin XM, Liu Y, Chi C, Lin CX, Yang Y. Efficacy of an absorbable polyglycolic acid patch in surgery for pneumothorax due to silicosis. J Cardiothorac Surg. 2012 Mar 6;7:18. doi: 10.1186/1749-8090-7-18. |
| 20426989 | Background | Lin XM, Lin CX, Chi C. [Application of absorbable Neoveil patch in operation on refractory pneumothorax in silicosis patients]. Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi. 2010 Jan;28(1):60-1. No abstract available. Chinese. |
| 19040924 | Background | Bialas RC, Weiner TM, Phillips JD. Video-assisted thoracic surgery for primary spontaneous pneumothorax in children: is there an optimal technique? J Pediatr Surg. 2008 Dec;43(12):2151-5. doi: 10.1016/j.jpedsurg.2008.08.041. |