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Ultrathin Bronchoscopy for Solitary Pulmonary Nodules

Ultrathin Bronchoscopy for Solitary Pulmonary Nodules: A Randomised Pilot Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02490059
Acronym
Babyscope
Enrollment
40
Registered
2015-07-03
Start date
2000-11-30
Completion date
2015-05-31
Last updated
2015-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

OTHERbronchoscopy

Bronchoscopy for diagnosis of pulmonary nodules

Sponsors

University of Stellenbosch
CollaboratorOTHER
University of Zurich
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* missing informed consent

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity2 yearsSensitivity 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.

Secondary

MeasureTime frameDescription
Diagnostic yield2 yearsDiagnostic yield of UB compared to SB. 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026