Endobronchial Valves in Persistent Air Leak

Malignant Neoplasm of Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451359
• Other study ID #: s51545
• Status: Completed
• Phase: N/A
• First received: October 4, 2011
• Last updated: October 8, 2013
• Start date: October 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2011
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Malignant Neoplasm of Lung
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical efficacy	Clinical efficacy on air leak cessation allowing drain(s) removal.	One month	Yes
Secondary	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.	One month	Yes