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Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications


N/A
10 Years
N/A
Open (Enrolling)
Both
Lung Neoplasm, Lung Diseases, Interstitial, Respiratory Tract Infections, Pleural Effusions

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Trial Information

Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications


Background: Respiratory endoscopy comprises flexible bronchoscopy and medical thoracoscopy.
The diagnostic yield, technical factors and complications for all patient sub-populations is
still not clearly defined. This may result in inappropriate or even dangerous application of
such procedures. The aim of the study is to collect data on these aspects of respiratory
endoscopy and identify important trends, as well as, areas for improvement. This data will
also provide baseline comparative data for new bronchoscopic techniques such as
endobronchial ultrasound and navigational bronchoscopy.

Method: Prospective data collection. Technical details regarding these procedures are
currently keyed into the OTM system by the endoscopy operators for documentation and
billing. The department of Respiratory and Critical Care Medicine gets monthly downloads of
all the fields from the OTM system for audit purposes.(See data collection form) The
research project proposes to make the data non identifiable by removing the patient's name
and IC number. Additionally the yield of the procedure will be checked by a chart review of
the histology and microbiology results. There are no restrictions on patient recruitment
because all procedures will be performed for clinical indications only and no patient will
be recruited for the sole purpose of the study. Waiver of consent has been obtained by the
IRB. The current estimated bronchoscopy load is 1000/year and data will be kept in the trial
co-coordinator's computer in a locked office. The investigators hope to run the database for
3 years initially.


Inclusion Criteria:



- All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion Criteria:

- Clinical contra-indications to respiratory endoscopy

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Endoscopy diagnostic yield

Outcome Description:

Positive and negative histology and microbiology yield

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Devanand Anantham, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Singapore General Hospital

Authority:

Singapore: Health Sciences Authority

Study ID:

2011/350/C

NCT ID:

NCT01374542

Start Date:

June 2011

Completion Date:

May 2013

Related Keywords:

  • Lung Neoplasm
  • Lung Diseases, Interstitial
  • Respiratory Tract Infections
  • Pleural Effusions
  • Bronchoscopy
  • Thoracoscopy
  • Neoplasms
  • Lung Diseases
  • Lung Neoplasms
  • Pleural Effusion
  • Respiratory Tract Infections
  • Lung Diseases, Interstitial

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