NCT02490059

Brief Summary

The evaluation of solitary pulmonary nodules (SPN) requires a balance between procedure-related morbidity and diagnostic yield, particularly in areas where tuberculosis is endemic. Data on ultrathin bronchoscopy (UB) for this purpose is limited. In this prospective randomised trial we compared diagnostic yield and adverse events of UB with standard-size bronchoscopy (SB) in a cohort of patients with SPN located beyond the visible range of SB.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 lung-cancer

Timeline
Completed

Started Nov 2000

Longer than P75 for phase_4 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed
11.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

3 years

First QC Date

June 25, 2015

Last Update Submit

July 1, 2015

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Sensitivity of the diagnosis of malignancy. Biopsy specimens obtained by bronchoscopy were compared with the diagnosis made by surgical resection or CT-guided trans-thoracic needle aspiration if applicable. Efforts were made to obtain confirmatory histological diagnosis for all patients. Alternatively, when invasive diagnosis was not feasible or appropriate (as assessed by a multidisciplinary tumour board) radiological follow-up examinations were performed over two years.

    2 years

Secondary Outcomes (1)

  • Diagnostic yield

    2 years

Study Arms (2)

Standard size bronchoscopy

ACTIVE COMPARATOR

ll procedures were started using SB with an external diameter of 5.0-6.0 mm with a biopsy channel of 2.2-2.8 mm (models Olympus BF-30 and BF-1T160, Olympus, Tokyo, Japan). If during SB the lesion was endoscopically visible the bronchoscopy was continued as standard diagnostic procedure and the patients were excluded from the analysis. Only if no tumour was visible during complete inspection of the bronchial tree using the SB, a participant was randomised by opening a numbered sealed opaque envelope. Randomisation was performed using sequentially numbered (1-40) sealed opaque envelopes (block randomisation: block size 4). For subjects allocated to the SB group, the examination was immediately continued with the same SB bronchoscope.

Other: bronchoscopy

Ultrahin bronchoscopy

EXPERIMENTAL

For subjects randomised to UB, the instrument was changed immediately to an Olympus BF-XP 40 ultrathin bronchoscope with an outer diameter of 2.8 mm and a working channel 1.2 mm during the same bronchoscopy session.

Other: bronchoscopy

Interventions

bronchoscopyOTHER

Bronchoscopy for diagnosis of pulmonary nodules

Standard size bronchoscopyUltrahin bronchoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pulmonary nodule on a recent CT
  • non-visible on standard-size bronchoscopy

You may not qualify if:

  • missing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

  • Franzen D, Diacon AH, Freitag L, Schubert PT, Wright CA, Schuurmans MM. Ultrathin bronchoscopy for solitary pulmonary lesions in a region endemic for tuberculosis: a randomised pilot trial. BMC Pulm Med. 2016 Apr 27;16(1):62. doi: 10.1186/s12890-016-0225-1.

    PMID: 27117455DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Daniel Franzen, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 3, 2015

Study Start

November 1, 2000

Primary Completion

November 1, 2003

Study Completion

May 1, 2015

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations

CH(1)