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Endobronchial Valves in Persistent Air Leak

Primary Purpose

Malignant Neoplasm of Lung

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
EndoBronchial Valve
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasm of Lung

Eligibility Criteria

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

Inclusion Criteria:

  • Prolonged (≥10 days postoperative) persistent air leak refractory to conventional treatments (such as prolonged drainage and/or chemical pleurodesis).
  • Anatomical lung resection such as segmentectomy, (bi)lobectomy or sleeve lobectomy.
  • Air leak after antero/posterolateral thoracotomy or video-assisted thoracoscopy (VATS).
  • Type of air leak : expiratory.
  • Size of air leak : any.

Exclusion Criteria:

  • Prolonged air leak <10 days postoperative.
  • Pneumonectomy or none-anatomical lung resection.
  • Lung resection for another indication than cancer.
  • Previous reintervention or previous Heimlich valve for this air leak.
  • Empyema

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

endobronchial valve

Arm Description

The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.

Outcomes

Primary Outcome Measures

clinical efficacy
Clinical efficacy on air leak cessation allowing drain(s) removal.

Secondary Outcome Measures

Safety
Complications related to endobronchial valve: fever, pulmonary infection, valve migration, pneumothorax requiring treatment. Avoidance of ambulatory Heimlich valve and re-operation. Timing of drain removal.

Full Information

First Posted
October 4, 2011
Last Updated
October 8, 2013
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01451359
Brief Title
Endobronchial Valves in Persistent Air Leak
Official Title
Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Because an endobronchial valve is a one-way inspiratory airway blocker, it is hypothesized that it could be also used for controlling persistent air leaks while maintaining the drainage of secretions. The U.S. Food and Drug Administration approved in October 2008 the Spiration valve system designed to control air leaks in the lung that persist after lung surgery. This prospective observational study aims to evaluate the efficacy and safety of Spiration endobronchial valves in a prospective series of consecutive patients with a prolonged persistent air leak after anatomic surgical resection for cancer.
Detailed Description
Persistent Air Leak (PAL) is independently associated with prolonged hospital length of stay, decreased patient satisfaction, increased morbidity or postoperative complications, and adds significantly to the cost. The management of air leaks is primarily preventive and therefore starts in the operating room with surgical techniques that can minimize the occurrence of post-operative air leaks, such as the creation of pleural tents or use of suture line glues or sealants. Notwithstanding some patients will after a lung resection have PAL. Any minimal invasive method that helps to increase our ability to treat (reduce and/or stop) the air leak in these latest cases carries an enormous clinical as well as cost-saving potential. Bronchoscopic occlusion of a segmental or subsegmental bronchus using endobronchial valves is such a less invasive method which has shown in case reports to interrupt an air leak.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endobronchial valve
Arm Type
Experimental
Arm Description
The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
Intervention Type
Device
Intervention Name(s)
EndoBronchial Valve
Other Intervention Name(s)
Spiration IBV™ valve system
Intervention Description
The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
Primary Outcome Measure Information:
Title
clinical efficacy
Description
Clinical efficacy on air leak cessation allowing drain(s) removal.
Time Frame
One month
Secondary Outcome Measure Information:
Title
Safety
Description
Complications related to endobronchial valve: fever, pulmonary infection, valve migration, pneumothorax requiring treatment. Avoidance of ambulatory Heimlich valve and re-operation. Timing of drain removal.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Prolonged (≥10 days postoperative) persistent air leak refractory to conventional treatments (such as prolonged drainage and/or chemical pleurodesis). Anatomical lung resection such as segmentectomy, (bi)lobectomy or sleeve lobectomy. Air leak after antero/posterolateral thoracotomy or video-assisted thoracoscopy (VATS). Type of air leak : expiratory. Size of air leak : any. Exclusion Criteria: Prolonged air leak <10 days postoperative. Pneumonectomy or none-anatomical lung resection. Lung resection for another indication than cancer. Previous reintervention or previous Heimlich valve for this air leak. Empyema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chrtistophe Dooms, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
24232700
Citation
Dooms CA, Decaluwe H, Yserbyt J, De Leyn P, Van Raemdonck D, Ninane V. Bronchial valve treatment for pulmonary air leak after anatomical lung resection for cancer. Eur Respir J. 2014 Apr;43(4):1142-8. doi: 10.1183/09031936.00117613. Epub 2013 Nov 14.
Results Reference
derived

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Endobronchial Valves in Persistent Air Leak

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