PneumothoraxNCT02352012
Interventional Treatment of Refractory Pneumothorax by Bronchoscope
A study testing Autologous blood and Bronchial plug in people with Pneumothorax, run by Tang-Du Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pneumothorax
- What is being tested?
- Autologous blood and Bronchial plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 269 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Spontaneous pneumothorax has been treating with thoracic closed drainage for 7 days, the patient has still persistent air leakage;
- Patients informed consent to participate in this study and can complete the requirements of the follow-up visit
Who cannot join
- Patients with severe abnormal gas exchange are defined as PaCO2>50mmHg(6.6kPa) or PaO2<45mmHg(6.0kPa) ;
- Patients have systemic disease or cancer which affect the survival time ;
- Patients have other serious diseases (the researchers think patient is not an appropriate candidate) which affect the evaluation or follow-up in research;
- Patients are not suitable for or unable to tolerate bronchoscopy procedures;
- Patients have active tuberculosis;
- Patients have any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints including interference test of nerves or skeletal muscle disease;
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- Patients have demonstrated unwillingness or inability to complete screening or baseline data collection procedures;
- Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study;
- Female patient of childbearing potential has a positive result from a pregnancy test.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Wangping Li, MD, 8618066620066; 862984778526, qxd25@163.com
Yun Li, MD, 8618629675387, littleyun@126.com
About this study
Official title: A Multi-site Randomized Controlled Study of Interventional Treatment of Refractory Pneumothorax by Bronchoscope
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.
Read the detailed description
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.
- Conditions
- Pneumothorax
- Being tested
- Autologous blood, Bronchial plug
- Keywords
- Interventional Treatment, Refractory Pneumothorax, Bronchoscope
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bloodOther
Autologous blood was perfused to the target pulmonary segment
Bronchial plugDevice
Bronchial plug was placed to the target pulmonary segment
| Study group | Role | What they receive |
|---|---|---|
| Autologous blood group A | Experimental | Autologous blood was perfused to the target pulmonary segment Receives: Other: Autologous blood |
| Bronchial plug group B | Experimental | Bronchial plug was placed to the target pulmonary segment Receives: Device: Bronchial plug |
| control group | No intervention | Control group was given to continuous negative pressure drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of air leakage
Measured: up to two weeks
Secondary outcomes (1)
duration of pulmonary atelectasis
Measured: up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionFeb 2015
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PneumothoraxStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Third Military Medical University, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Faguang Jin, MD & PhD, Principal investigator, Tang-Du Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352012
- Sponsor's protocol ID
- tdhx007
- Other IDs
- 201402024007
- Status last verified
- Jan 2016
- First submitted
- 18 Nov 2014
- Last updated
- 6 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25336533Cundiff 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.
PubMed 24528320Yamashita 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.
PubMed 23917049Odaka 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.
PubMed 23107020Iyama 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.
PubMed 22864128Lin 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.
PubMed 22394587Lin 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.
PubMed 20426989Bialas 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.
PubMed 19040924
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Randomized Controlled Study of Interventional Treatment of Refractory Pneumothorax by Bronchoscope
- ClinicalTrials.gov ID
- NCT02352012
- Acronym / sponsor ID
- tdhx007
- Conditions
- Pneumothorax
- Keywords
- Interventional Treatment, Refractory Pneumothorax, Bronchoscope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 269 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Collaborators
- Changhai Hospital, The First Affiliated Hospital of Guangzhou Medical University, Second Affiliated Hospital of Third Military Medical University, China Meitan General Hospital, MICRO-TECH (Nanjing) Co., Ltd
- Study start
- Feb 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Autologous blood group A | Experimental | Other: Autologous bloodAutologous blood was perfused to the target pulmonary segment |
| Bronchial plug group B | Experimental | Device: Bronchial plugBronchial plug was placed to the target pulmonary segment |
| control group | No intervention | –Control group was given to continuous negative pressure drainage |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Spontaneous pneumothorax has been treating with thoracic closed drainage for 7 days, the patient has still persistent air leakage;
- Patients informed consent to participate in this study and can complete the requirements of the follow-up visit
Key exclusion criteria (9 listed)
- Patients with severe abnormal gas exchange are defined as PaCO2>50mmHg(6.6kPa) or PaO2<45mmHg(6.0kPa) ;
- Patients have systemic disease or cancer which affect the survival time ;
- Patients have other serious diseases (the researchers think patient is not an appropriate candidate) which affect the evaluation or follow-up in research;
- Patients are not suitable for or unable to tolerate bronchoscopy procedures;
- Patients have active tuberculosis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous bloodAutologous blood was perfused to the target pulmonary segment | Other | Autologous blood group A |
| Bronchial plugBronchial plug was placed to the target pulmonary segment | Device | Bronchial plug group B |
Primary outcome
Duration of air leakage
Time frame: up to two weeks
1 secondary outcome
duration of pulmonary atelectasis
Time frame: up to two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2016.
- Background: PubMed 25336533Gilbert 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.
- Background: PubMed 24528320Cundiff 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.
- Background: PubMed 23917049Yamashita 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.
- Background: PubMed 23107020Odaka 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.
- Background: PubMed 22864128Iyama 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.
- Background: PubMed 22394587Lin 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.
- Background: PubMed 20426989Lin 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.
- Background: PubMed 19040924Bialas 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.
- Click here for more information about this study: different treatment methods for different causes of pneumothoraxLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faguang Jin, MD & PhD principal investigator
Tang-Du Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous blood and Bronchial plug in people with Pneumothorax, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wangping Li, MD (8618066620066; 8629-778526, qxd25@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of air leakage (time frame: up to two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02352012, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2016.