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Completed

NCT Number: NCT01451359

Endobronchial Valves in Persistent Air Leak

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endobronchial Valve

Device

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

Other names: Spiration IBV™ valve system

Primary outcomes

  1. clinical efficacy

    Time frame: One month

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Efficacy of Endobronchial Valves in Persistent Air Leak After Anatomical Pulmonary Resection for Cancer.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 13, 2011
Registry last updated
Oct 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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