Interventional Treatment of Refractory Pneumothorax by Bronchoscope

NCT ID: NCT02352012

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-06-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous blood group A

Autologous blood was perfused to the target pulmonary segment

Group Type: EXPERIMENTAL

Autologous blood

Intervention Type: OTHER

Autologous blood was perfused to the target pulmonary segment

Bronchial plug group B

Bronchial plug was placed to the target pulmonary segment

Group Type: EXPERIMENTAL

Bronchial plug

Intervention Type: DEVICE

Bronchial plug was placed to the target pulmonary segment

control group

Control group was given to continuous negative pressure drainage

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Autologous blood

Autologous blood was perfused to the target pulmonary segment

Intervention Type: OTHER

Bronchial plug

Bronchial plug was placed to the target pulmonary segment

Intervention Type: DEVICE

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Third Military Medical University

OTHER

Sponsor Role: collaborator

China Meitan General Hospital

OTHER

Sponsor Role: collaborator

Micro-Tech (Nanjing) Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Tang-Du Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faguang Jin, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Tang-Du Hospital

Locations

Tangdu Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wangping Li, MD

Role: CONTACT

qxd25@163.com

8618066620066; 8629-778526

Yun Li, MD

Role: CONTACT

littleyun@126.com

8618629675387

Facility Contacts

Wangping Li, MD

Role: primary

qxd25@163.com

8618066620066; 862984778526

Yun Li, MD

Role: backup

littleyun@126.com

8618629675387

References

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Reference Type: BACKGROUND

PMID: 25336533 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24528320 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23917049 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23107020 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22864128 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22394587 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20426989 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19040924 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed

Click here for more information about this study: different treatment methods for different causes of pneumothorax

Other Identifiers

201402024007

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

tdhx007

Identifier Type: -

Identifier Source: org_study_id