Ultrathin Bronchoscopy for Solitary Pulmonary Nodules

Ultrathin Bronchoscopy for Solitary Pulmonary Nodules: A Randomised Pilot Trial

Sponsors

Lead Sponsor: University of Zurich

Collaborator: University of Stellenbosch

Source University of Zurich
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.

Detailed Description

The present prospective single-centre randomised pilot study was performed at Tygerberg Academic Hospital, a tertiary university hospital in Cape Town, South Africa, with a referral drainage area of 1.5 million people and tuberculosis notification rate of up to 1'000/100'000 persons per year when the study was performed. Between November 2000 and November 2003 all patients referred to the lung unit with single pulmonary lesion ≤ 6 cm in diameter on chest computed tomography (CT) were included. SPN was defined as a single and circumscribed pulmonary lesion with a diameter ≤ 6.0 cm, surrounded by aerated lung tissue, and without evidence of atelectasis, pneumonitis, or cavity on CT scan. Location and maximal diameter of all SPNs were recorded from the chest CT prior to enrolment of patients. Inclusion criteria were a previous cytological and microbiological negative sputum examination, absence of enlarged mediastinal or hilar lymph nodes on chest CT scan, and informed consent obtained before start of the procedure. Exclusion criteria were SPN with lesion size unchanged over two years, inability to undergo bronchoscopy or thoracotomy, and pregnancy. Participants with consent for participation in the study in whom the lesion was found to be visible on SB were then not randomised and not considered part of the study population. Written informed consent was obtained from all patients before inclusion in the study.

Overall Status Completed
Start Date November 2000
Completion Date May 2015
Primary Completion Date November 2003
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Sensitivity 2 years
Secondary Outcome
Measure Time Frame
Diagnostic yield 2 years
Enrollment 40
Condition
Intervention

Intervention Type: Other

Intervention Name: bronchoscopy

Description: Bronchoscopy for diagnosis of pulmonary nodules

Eligibility

Criteria:

Inclusion Criteria:

- Pulmonary nodule on a recent CT

- non-visible on standard-size bronchoscopy

Exclusion Criteria:

- missing informed consent

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Daniel Franzen, MD Principal Investigator University of Zurich
Location
Facility: University Hospital Zurich
Location Countries

Switzerland

Verification Date

July 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Zurich

Investigator Full Name: Daniel Franzen

Investigator Title: Medical Doctor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Standard size bronchoscopy

Type: Active Comparator

Description: 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.

Label: Ultrahin bronchoscopy

Type: Experimental

Description: 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.

Acronym Babyscope
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov