Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Ultrathin Bronchoscopy for Solitary Pulmonary Nodules (Babyscope)

1. juli 2015 oppdatert av: Daniel Franzen, University of Zurich

Ultrathin Bronchoscopy for Solitary Pulmonary Nodules: A Randomised Pilot Trial

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Zurich, Sveits, 8091
        • University Hospital Zurich

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • missing informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.
Annen: bronchoscopy
Bronchoscopy for diagnosis of pulmonary nodules
Eksperimentell: 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.
Annen: bronchoscopy
Bronchoscopy for diagnosis of pulmonary nodules

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sensitivity
Tidsramme: 2 years
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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Diagnostic yield
Tidsramme: 2 years
Diagnostic 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.
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Zurich

Samarbeidspartnere

University of Stellenbosch

Etterforskere

  • Hovedetterforsker: Daniel Franzen, MD, University of Zurich

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2000

Primær fullføring (Faktiske)

1. november 2003

Studiet fullført (Faktiske)

1. mai 2015

Datoer for studieregistrering

Først innsendt

25. juni 2015

Først innsendt som oppfylte QC-kriteriene

1. juli 2015

Først lagt ut (Anslag)

3. juli 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

3. juli 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juli 2015

Sist bekreftet

1. juli 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2000-C094

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Lungekreft

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Suriname

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere