Endobronchial Valves in Persistent Air Leak

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01451359
First received: October 4, 2011
Last updated: October 8, 2013
Last verified: October 2011
  Purpose

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 Intervention
Malignant Neoplasm of Lung
Device: EndoBronchial Valve

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • clinical efficacy [ Time Frame: One month ] [ Designated as safety issue: Yes ]
    Clinical efficacy on air leak cessation allowing drain(s) removal.


Secondary Outcome Measures:
  • Safety [ Time Frame: One month ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 10
Study Start Date: October 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451359

Locations
Belgium
University Hospitals Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Chrtistophe Dooms, MD, PhD Universitaire Ziekenhuizen Leuven
  More Information

No publications provided by Universitaire Ziekenhuizen Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01451359     History of Changes
Other Study ID Numbers: s51545
Study First Received: October 4, 2011
Last Updated: October 8, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014