Clinical trial NCT02490059: Ultrathin Bronchoscopy for Solitary Pulmonary Nodules
Official title: Ultrathin Bronchoscopy for Solitary Pulmonary Nodules: A Randomised Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
First posted: 2015-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* missing informed consent

Primary outcomes:
measure: Sensitivity
timeFrame: 2 years
Secondary outcomes:
measure: Diagnostic yield
timeFrame: 2 years
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Daniel Franzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.