CClinicalTrials.gg
Status unknownNCT02352012Updated Jan 6, 2016

Interventional Treatment of Refractory Pneumothorax by Bronchoscope

An interventional study of Autologous blood and Bronchial plug in Pneumothorax, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-01-06.

Sponsored by Tang-Du Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
269
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Pneumothorax

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Keywords

  • Interventional Treatment
  • Refractory Pneumothorax
  • Bronchoscope
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In context

Pneumothorax

178 studies on the registry are indexed under Pneumothorax; 42 are open to participants now.

This study's planned enrollment of 269 is above the median of 100 across 115 interventional studies indexed under Pneumothorax.

Browse Pneumothorax studies →

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
269 participants (estimated)

Study arms

  • Experimental
    Autologous blood group A

    Autologous blood was perfused to the target pulmonary segment

    Other: Autologous blood

  • Experimental
    Bronchial plug group B

    Bronchial plug was placed to the target pulmonary segment

    Device: Bronchial plug

  • No intervention
    control group

    Control group was given to continuous negative pressure drainage

Interventions

  • OtherAutologous blood

    Autologous blood was perfused to the target pulmonary segment

  • DeviceBronchial plug

    Bronchial plug was placed to the target pulmonary segment

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What researchers measure

Primary outcomes

  1. Duration of air leakage

    Time frame: up to two weeks

Secondary outcomes

  1. duration of pulmonary atelectasis

    Time frame: up to two weeks

Other outcomes

  1. Arterial blood gas

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  2. complications

    Complications refers to the complications related to bronchoscopy treatment(include hemoptysis, short of breath, chest pain, fever )

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  3. hospital costs

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

  4. Duration of hospital stays

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks

07

Study locations

1 of 1 sites recruiting
  • Tangdu Hospital
    Xi'an, Shaanxi 710038, China
    • Wangping Li, MD · Contact · qxd25@163.com · 8618066620066; 862984778526
    • Yun Li, MD · Contact · littleyun@126.com · 8618629675387
    • Wangping Li, MD · Principal investigator
    Recruiting
08

References and documents

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 25336533 ↗
  • 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. PubMed 24528320 ↗
  • 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. PubMed 23917049 ↗
  • 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. PubMed 23107020 ↗
  • 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. PubMed 22864128 ↗
  • 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. PubMed 22394587 ↗
  • 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. PubMed 20426989 ↗
  • 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. PubMed 19040924 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02352012
Lead sponsor
Tang-Du Hospital
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
First posted
Jan 30, 2015
Start date
Feb 2015
Primary completion
Feb 2015
Completion
Jun 2017 (estimated)
Last update
Jan 6, 2016

Study contacts

Wangping Li, MD
Contact
qxd25@163.com
8618066620066; 8629-778526
Yun Li, MD
Contact
littleyun@126.com
8618629675387
Faguang Jin, MD & PhD
principal investigator · Tang-Du Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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