Interventional Treatment of Refractory Pneumothorax by Bronchoscope

Pneumothorax Clinical Trial

Official title:

A Multi-site Randomized Controlled Study of Interventional Treatment of Refractory Pneumothorax by Bronchoscope

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352012
• Other study ID #: tdhx007
• Secondary ID: 201402024007
• Status: Recruiting
• Phase: N/A
• First received: November 18, 2014
• Last updated: January 4, 2016
• Start date: February 2015
• Est. completion date: June 2017

Study information

• Verified date: January 2016
• Source: Tang-Du Hospital
• Contact: Wangping Li, MD
• Phone: 8618066620066; 8629-778526
• Email: qxd25[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 269
• Est. completion date: June 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumothorax

Intervention

Other:
• Autologous blood
Autologous blood was perfused to the target pulmonary segment

Device:
• Bronchial plug
Bronchial plug was placed to the target pulmonary segment

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi`an	Shaanxi

Sponsors (6)

Lead Sponsor	Collaborator
Tang-Du Hospital	Changhai Hospital, China Meitan General Hospital, Micro-Tech (Nanjing) Co., Ltd., Second Affiliated Hospital of Third Military Medical University, The First Affiliated Hospital of Guangzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2012 Aug 1. — View Citation

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. Chinese. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Arterial blood gas		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Other	complications	Complications refers to the complications related to bronchoscopy treatment(include hemoptysis, short of breath, chest pain, fever )	participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Other	hospital costs		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Other	Duration of hospital stays		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Primary	Duration of air leakage		up to two weeks	Yes
Secondary	duration of pulmonary atelectasis		up to two weeks	Yes

External Links

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