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

18 Years
Open (Enrolling)
Malignant Neoplasm of Lung

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Trial Information

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

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.

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

clinical efficacy

Outcome Description:

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

Outcome Time Frame:

One month

Safety Issue:


Principal Investigator

Chrtistophe Dooms, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

October 2011

Completion Date:

March 2013

Related Keywords:

  • Malignant Neoplasm of Lung
  • Neoplasms
  • Lung Neoplasms