Outcome After Treatment of Pulmonary Aspergilloma

Pulmonary Fungal Diseases Clinical Trial

Official title:

Outcome After Surgical Treatment or Bronchial Embolisation in Aspergilloma of the Lung: a Single Center Experience.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01958710
• Other study ID #: ASPERLEU
• Status: Active, not recruiting
• Phase: N/A
• First received: October 7, 2013
• Last updated: October 7, 2013
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: October 2013
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Observational

Clinical Trial Summary

Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.

Description:

A retrospective chart analysis, based on the search results from a thoracic surgery database and an interventional radiology database. Outcome analysis of all surgically treated patients for a confirmed invasive aspergilloma. Comparisson with (preoperative) embolisation of the bronchial circulation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 89 Years

Eligibility

Inclusion Criteria:

• Histological proven Aspergilloma of the lung

Exclusion Criteria:

• Treatment limited to the use of systemic antifungal agents

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Lung Diseases, Fungal
• Mycoses
• Pulmonary Fungal Diseases

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	survival after treatment	estimated 10 yaer survival after treatment for pulmonary aspergilloma	10 years	No
Secondary	post treatment survival	survival status at 90 days after initiation of treatment	90 days	No