Clinical trial NCT01451359: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Lung
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-10-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical efficacy
timeFrame: One month
Secondary outcomes:
measure: Safety
timeFrame: One month
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Chrtistophe Dooms, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.