Contact information
Type
Scientific
Primary contact
Dr Juergen Hetzel
ORCID ID
Contact details
Department of Internal Medicine II
University of Tuebingen
Otfried-Müller-Str. 10
Tuebingen
72076
Germany
juergen.hetzel@med.uni-tuebingen.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised prospective controlled study for the comparison of forceps biopsy and cryobiopsy in bronchoscopically visible pulmonary lesions
Acronym
Study hypothesis
In patients with endobronchially tumour suspicious lesions cryobiopsy shows a higher sensitivity than forceps biopsy.
Ethics approval
The corresponding ethics committees and the institutional review boards approved the study protocol. All other centres will seek ethics approval before recruiting participants.
Study design
Prospective randomised controlled partially blinded multicentre parallel-group study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bronchoscopically visible pulmonary lesions
Intervention
This was a prospective, randomised, partially blinded multicentre study. A total of 600 patients with suspected endobronchial tumours were investigated. Patients were randomised either to sampling using forceps or the cryoprobe. After obtaining biopsy samples a blinded histological evaluation was performed. Follow-up occurred until the timepoint a definitive diagnosis was obtained either by the investigated biopsy methods or by an additional diagnostic method. According to the definitive clinical diagnosis sensitivity for malignancy was evaluated. Procedure related factors such as duration of procedure (i.e. biopsy sampling plus haemostatic measures), anaesthetic requirements and also the adverse event rate were recorded. A follow-up to guarantee patients safety was not necessary in this case since the intervention was biopsy sampling for diagnostics purposes.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Sensitivity of forceps biopsy versus cryobiopsy: The biopsy technique utilised was regarded as successful, when histological confirmation of the diagnosis was achieved at the initial bronchoscopy and matched the final diagnosis. If additional tests, e.g. further bronchoscopies, surgery etc. were needed to establish the tumour diagnosis, the biopsy was regarded as not diagnostic.
Secondary outcome measures
1. Bleeding frequency and severity: none/mild (no intervention)/severe (at least one intervention for bleeding control applied)
2. The number of samples taken (per protocol the number of biopsies needed was left to the bronchoscopist's discretion with a suggested maximum limit of four samples)
3. Localisation
4. Classification of tumour into exophytic or submucosal growth
5. Level of difficulty to position the probe (easy, moderate or difficult)
6. Duration of the procedure
7. Historical parameters such as quality and size of the samples
8. Need of additional measures, e.g., immunohistology
9. Bronchoscopy technique (rigid/flexible)
10. Quality of histology
11. Influence of forceps size upon diagnostic yield and sample size
12. Diagnostic yield of forceps biopsy versus cryobiopsy in the whole study population
All assessed intra-/peri-procedural.
Overall trial start date
01/06/2005
Overall trial end date
30/10/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinical indication for a biopsy of an endoscopically visible endobronchial lesion suspicious for tumour
2. Aged older than 18 years, either sex
3. Signed declaration of consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. Haemorrhagic diathesis/anticoagulation
2. Oxygen saturation under 2 l/min less than 90%
3. Severe underlying cardiac disease (unstable angina pectoris, myocardial infarction in the past month, decompensated cardiac insufficiency)
Recruitment start date
01/06/2005
Recruitment end date
30/10/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Internal Medicine II
Tuebingen
72076
Germany
Sponsor information
Organisation
University Clinical Center Tuebingen (Germany) - represented by its management
Sponsor details
c/o Dr Juergen Hetzel
Department of Internal Medicine II
Otfried-Müller-Str. 10
Tübingen
72076
Germany
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
ERBE Elektromedizin GmbH (Germany) - provided cryoprobes and 15 per patient for documentation and additional histological slides
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list