Outcome After Treatment of Pulmonary Aspergilloma

October 7, 2013 updated by: Johnny Moons, University Hospital, Gasthuisberg

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

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

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • University Hospital Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 89 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients in the database with following interventions will be screened for invasive aspergilloma in the final resection specimen:

Aspergilloma Fungal disease Lung bleeding Destroyed lung Empyema of the lung

Description

Inclusion Criteria:

  • Histological proven Aspergilloma of the lung

Exclusion Criteria:

  • Treatment limited to the use of systemic antifungal agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Embolisation
(preoperative) embolisation of the bronchial circulation
Surgery
Any surgically treated patient with a functional lung resection (at least wedge resection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
survival after treatment
Time Frame: 10 years
estimated 10 yaer survival after treatment for pulmonary aspergilloma
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post treatment survival
Time Frame: 90 days
survival status at 90 days after initiation of treatment
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Herbert Decaluwé, MD, UZ Leuven - dept. Thoracic Surgery
  • Principal Investigator: Laurence Bertrand, MSc, Katholic University Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (Estimate)

October 9, 2013

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 7, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASPERLEU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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