Respiratory Endoscopy: Diagnostic Yield, Technical Factors and Complications

NCT01374542 — Completed, 4000 participants, Singapore General Hospital

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT01374542
StatusCompleted
Study typeObservational
Enrollment4000 (Actual)
SponsorSingapore General Hospital (Other)
ConditionsLung Neoplasm, Lung Diseases, Interstitial, Respiratory Tract Infections, Pleural Effusions
InterventionsRespiratory endoscopy (Procedure)
Datesstart 2011-06-01, primary completion 2021-01-01, completion 2021-01-01, first posted 2011-06-16, last updated 2021-10-01
Locations1 site in Singapore

Related Papers Related Patents Related Grants Related Experts
All trials for Lung Neoplasm All trials for Lung Diseases, Interstitial All trials of Respiratory endoscopy

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Respiratory endoscopy patientsProcedure: Respiratory endoscopyPatients undergoing respiratory endoscopy at Singapore General Hospital
  • Respiratory endoscopy (Procedure), also known as Bronchoscopy-Flexible bronchoscopy, Thoracoscopy-Pleuroscopy, Endobronchial ultrasound-EBUS: Bronchoscopy, thoracoscopy, endobronchial ultrasound

+Outcome measures

Primary outcomes

  • 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

Sex: All, ages: 10 Years to 100 Years

Inclusion Criteria:

* All patients undergoing respiratory endoscopy at Singapore General Hospital

Exclusion Criteria:

* Clinical contra-indications to respiratory endoscopy

+Locations (1)

FacilityCityCountryStatus
Singapore General HospitalSingaporeSingapore

+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. PMID 14612897
  • 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
  • Results publication: 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
  • Results publication: 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
  • Results publication: 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

+Investigators