Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

NCT ID: NCT01374542

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2021-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lung Neoplasm Lung Diseases, Interstitial Respiratory Tract Infections Pleural Effusions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Respiratory endoscopy patients

Patients undergoing respiratory endoscopy at Singapore General Hospital

Respiratory endoscopy

Intervention Type PROCEDURE

Bronchoscopy, thoracoscopy, endobronchial ultrasound

Interventions

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Respiratory endoscopy

Bronchoscopy, thoracoscopy, endobronchial ultrasound

Intervention Type PROCEDURE

Other Intervention Names

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Bronchoscopy-Flexible bronchoscopy Thoracoscopy-Pleuroscopy Endobronchial ultrasound-EBUS

Eligibility Criteria

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Inclusion Criteria

* All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion Criteria

* Clinical contra-indications to respiratory endoscopy
Minimum Eligible Age

10 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Devanand Anantham, MRCP

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

References

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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. doi: 10.1038/sj.bjc.6601368.

Reference Type BACKGROUND
PMID: 14612897 (View on PubMed)

Torrington KG, Kern JD. The utility of fiberoptic bronchoscopy in the evaluation of the solitary pulmonary nodule. Chest. 1993 Oct;104(4):1021-4. doi: 10.1378/chest.104.4.1021.

Reference Type BACKGROUND
PMID: 8404158 (View on PubMed)

Quek JC, Tan QL, Allen JC, Anantham D. Malignant pleural effusion survival prognostication in an Asian population. Respirology. 2020 Dec;25(12):1283-1291. doi: 10.1111/resp.13837. Epub 2020 May 11.

Reference Type DERIVED
PMID: 32390227 (View on PubMed)

Choo R, Naser NSH, Nadkarni NV, Anantham D. Utility of bronchoalveolar lavage in the management of immunocompromised patients presenting with lung infiltrates. BMC Pulm Med. 2019 Feb 26;19(1):51. doi: 10.1186/s12890-019-0801-2.

Reference Type DERIVED
PMID: 30808314 (View on PubMed)

De Roza MA, Quah KH, Tay CK, Toh W, Li H, Kalyanasundaram G, Anantham D. Diagnosis of Peripheral Lung Lesions via Conventional Flexible Bronchoscopy with Multiplanar CT Planning. Pulm Med. 2016;2016:5048961. doi: 10.1155/2016/5048961. Epub 2016 Nov 13.

Reference Type DERIVED
PMID: 27957340 (View on PubMed)

Other Identifiers

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2011/350/C

Identifier Type: -

Identifier Source: org_study_id

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