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Endobronchial Valves in Persistent Air Leak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01451359
Recruitment Status : Completed
First Posted : October 13, 2011
Last Update Posted : October 10, 2013
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm of Lung Device: EndoBronchial Valve Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.
Study Start Date : October 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: endobronchial valve
The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
Device: EndoBronchial Valve
The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
Other Name: Spiration IBV™ valve system

Primary Outcome Measures :
  1. clinical efficacy [ Time Frame: One month ]
    Clinical efficacy on air leak cessation allowing drain(s) removal.

Secondary Outcome Measures :
  1. Safety [ Time Frame: One month ]
    • 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01451359

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University Hospitals Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Chrtistophe Dooms, MD, PhD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01451359    
Other Study ID Numbers: s51545
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: October 10, 2013
Last Verified: October 2011
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases