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Interventional Treatment of Refractory Pneumothorax by Bronchoscope

Primary Purpose

Pneumothorax

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Autologous blood

Bronchial plug

About this trial

This is an interventional treatment trial for Pneumothorax focused on measuring Interventional Treatment, Refractory Pneumothorax, Bronchoscope

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Tangdu HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Autologous blood group A

Bronchial plug group B

control group

Arm Description

Autologous blood was perfused to the target pulmonary segment

Bronchial plug was placed to the target pulmonary segment

Control group was given to continuous negative pressure drainage

Outcomes

Primary Outcome Measures

Duration of air leakage

Secondary Outcome Measures

duration of pulmonary atelectasis

Full Information

NCT ID

NCT02352012

First Posted

November 18, 2014

Last Updated

January 4, 2016

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.

1. Study Identification

Unique Protocol Identification Number

NCT02352012

Brief Title

Interventional Treatment of Refractory Pneumothorax by Bronchoscope

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tang-Du Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumothorax

Keywords

Interventional Treatment, Refractory Pneumothorax, Bronchoscope

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

269 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Autologous blood group A

Arm Type

Experimental

Arm Description

Autologous blood was perfused to the target pulmonary segment

Arm Title

Bronchial plug group B

Arm Type

Experimental

Arm Description

Bronchial plug was placed to the target pulmonary segment

Arm Title

control group

Arm Type

No Intervention

Arm Description

Control group was given to continuous negative pressure drainage

Intervention Type

Other

Intervention Name(s)

Autologous blood

Intervention Description

Autologous blood was perfused to the target pulmonary segment

Intervention Type

Device

Intervention Name(s)

Bronchial plug

Intervention Description

Bronchial plug was placed to the target pulmonary segment

Primary Outcome Measure Information:

Title

Duration of air leakage

Time Frame

up to two weeks

Secondary Outcome Measure Information:

Title

duration of pulmonary atelectasis

Time Frame

up to two weeks

Other Pre-specified Outcome Measures:

Title

Arterial blood gas

Time Frame

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

Title

complications

Description

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

Title

hospital costs

Time Frame

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

Title

Duration of hospital stays

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wangping Li, MD

Phone

8618066620066; 8629-778526

qxd25@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yun Li, MD

Phone

8618629675387

littleyun@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Faguang Jin, MD & PhD

Organizational Affiliation

Tang-Du Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tangdu Hospital

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710038

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wangping Li, MD

Phone

8618066620066; 862984778526

qxd25@163.com

First Name & Middle Initial & Last Name & Degree

Yun Li, MD

Phone

8618629675387

littleyun@126.com

First Name & Middle Initial & Last Name & Degree

Wangping Li, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

25336533

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.

Results Reference

background

PubMed Identifier

24528320

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. No abstract available.

Results Reference

background

PubMed Identifier

23917049

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.

Results Reference

background

PubMed Identifier

23107020

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.

Results Reference

background

PubMed Identifier

22864128

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. doi: 10.2169/internalmedicine.51.7355. Epub 2012 Aug 1.

Results Reference

background

PubMed Identifier

22394587

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.

Results Reference

background

PubMed Identifier

20426989

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. No abstract available. Chinese.

Results Reference

background

PubMed Identifier

19040924

Citation

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.

Results Reference

background

Links:

URL

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

Description

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Interventional Treatment of Refractory Pneumothorax by Bronchoscope

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