Ultrathin Bronchoscopy for Solitary Pulmonary Nodules

NCT ID: NCT02490059

Last Updated: 2015-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-11-30
• Study Completion Date: 2015-05-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Standard size bronchoscopy

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.

Group Type: ACTIVE_COMPARATOR

bronchoscopy

Intervention Type: OTHER

Bronchoscopy for diagnosis of pulmonary nodules

Ultrahin bronchoscopy

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.

Group Type: EXPERIMENTAL

bronchoscopy

Intervention Type: OTHER

Bronchoscopy for diagnosis of pulmonary nodules

Interventions

bronchoscopy

Bronchoscopy for diagnosis of pulmonary nodules

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• missing informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Stellenbosch

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Daniel Franzen

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Franzen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 27117455 (View on PubMed)

Other Identifiers

2000-C094

Identifier Type: -

Identifier Source: org_study_id