Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

NCT01374542 | Completed

• 1 other identifier: 2011/350/C
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasm; Lung Diseases, Interstitial; Respiratory Tract Infections; Pleural Effusions

Keywords

Bronchoscopy; Thoracoscopy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Respiratory endoscopy patients

Patients undergoing respiratory endoscopy at Singapore General Hospital

Procedure: Respiratory endoscopy

Interventions

Respiratory endoscopy PROCEDURE

Bronchoscopy, thoracoscopy, endobronchial ultrasound

Also known as: Bronchoscopy-Flexible bronchoscopy, Thoracoscopy-Pleuroscopy, Endobronchial ultrasound-EBUS

Respiratory endoscopy patients

Eligibility Criteria

• Age: 10 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients undergoing respiratory endoscopy at Singapore General Hospital

You may qualify if:

• All patients undergoing respiratory endoscopy at Singapore General Hospital

You may not qualify if:

• Clinical contra-indications to respiratory endoscopy

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 168753, Singapore

Location

Related Publications (5)

• 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.

  PMID: 14612897 BACKGROUND

• 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.

  PMID: 8404158 BACKGROUND

• 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.

  PMID: 32390227 DERIVED

• 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.

  PMID: 30808314 DERIVED

• 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.

  PMID: 27957340 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases, Interstitial; Respiratory Tract Infections; Pleural Effusion

Interventions

Thoracoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Infections; Pleural Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Devanand Anantham, MRCP

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2011
• First Posted: June 16, 2011
• Study Start: June 1, 2011
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

SG (1)