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 approved by the IRB.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Lung Diseases, Interstitial; Lung Neoplasm; Pleural Effusions
• Intervention / Treatment: Procedure: Respiratory endoscopy

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 Type: Observational
• Enrollment (Actual): 4000

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 168753
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients undergoing respiratory endoscopy at Singapore General Hospital

Description

Inclusion Criteria:

• All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion Criteria:

• Clinical contra-indications to respiratory endoscopy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Respiratory endoscopy patients; Patients undergoing respiratory endoscopy at Singapore General Hospital	Procedure: Respiratory endoscopy; Bronchoscopy, thoracoscopy, endobronchial ultrasound; Other Names: Bronchoscopy-Flexible bronchoscopy; Thoracoscopy-Pleuroscopy; Endobronchial ultrasound-EBUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopy diagnostic yield	Positive and negative histology and microbiology yield	1 year
Endoscopy technical factors	Duration, sedation requirements, consumables	1 year
Endoscopy safety	Complication rate, need for escalation of care	1 year

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Devanand Anantham, MRCP, Singapore General Hospital

Publications and helpful links

General 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. doi: 10.1038/sj.bjc.6601368.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: June 15, 2011
• First Posted (Estimate): June 16, 2011

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Bronchoscopy; Thoracoscopy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Lung Neoplasms; Respiratory Tract Infections; Lung Diseases, Interstitial; Pleural Effusion
• Other Study ID Numbers: 2011/350/C