Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications
Study Details
Study Description
Brief Summary
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 approved by the IRB.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Respiratory endoscopy patients Patients undergoing respiratory endoscopy at Singapore General Hospital |
Procedure: Respiratory endoscopy
Bronchoscopy, thoracoscopy, endobronchial ultrasound
Other Names:
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Outcome Measures
Primary Outcome Measures
- Endoscopy diagnostic yield [1 year]
Positive and negative histology and microbiology yield
- Endoscopy technical factors [1 year]
Duration, sedation requirements, consumables
- Endoscopy safety [1 year]
Complication rate, need for escalation of care
Eligibility Criteria
Criteria
Inclusion Criteria:
- All patients undergoing respiratory endoscopy at Singapore General Hospital
Exclusion Criteria:
- Clinical contra-indications to respiratory endoscopy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Singapore General Hospital | Singapore | Singapore | 168753 |
Sponsors and Collaborators
- Singapore General Hospital
Investigators
- Principal Investigator: Devanand Anantham, MRCP, Singapore General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Kawaraya M, Gemba K, Ueoka H, Nishii K, Kiura K, Kodani T, Tabata M, Shibayama T, Kitajima T, Tanimoto M. Evaluation of various cytological examinations by bronchoscopy in the diagnosis of peripheral lung cancer. Br J Cancer. 2003 Nov 17;89(10):1885-8.
- Torrington KG, Kern JD. The utility of fiberoptic bronchoscopy in the evaluation of the solitary pulmonary nodule. Chest. 1993 Oct;104(4):1021-4.
- 2011/350/C