Comparison of forceps biopsy and cryobiopsy in bronchoscopically visible pulmonary lesions

ISRCTN	ISRCTN97376650
DOI	https://doi.org/10.1186/ISRCTN97376650
Secondary identifying numbers	N/A

Submission date: 01/12/2009
Registration date: 19/01/2010
Last edited: 29/12/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Juergen Hetzel
Scientific

Department of Internal Medicine II
University of Tuebingen
Otfried-Müller-Str. 10
Tuebingen
72076
Germany

Email	juergen.hetzel@med.uni-tuebingen.de

Study information

Study design	Prospective randomised controlled partially blinded multicentre parallel-group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised prospective controlled study for the comparison of forceps biopsy and cryobiopsy in bronchoscopically visible pulmonary lesions
Study objectives	In patients with endobronchially tumour suspicious lesions cryobiopsy shows a higher sensitivity than forceps biopsy.
Ethics approval(s)	The corresponding ethics committees and the institutional review boards approved the study protocol. All other centres will seek ethics approval before recruiting participants.
Health condition(s) or problem(s) studied	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
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 study start date	01/06/2005
Completion date	30/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	600
Total final enrolment	593
Key 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
Key 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)
Date of first enrolment	01/06/2005
Date of final enrolment	30/10/2008

Locations

Countries of recruitment

Germany

Study participating centre

Department of Internal Medicine II

Tuebingen
72076
Germany

Sponsor information

University Clinical Center Tuebingen (Germany) - represented by its management
University/education

c/o Dr Juergen Hetzel
Department of Internal Medicine II
Otfried-Müller-Str. 10
Tübingen
72076
Germany

Website	http://www.uni-tuebingen.de/uni/qvr/e-30/m30-01.html
"ROR"	https://ror.org/00pjgxh97

Funders

Funder type

Industry

ERBE Elektromedizin GmbH (Germany) - provided cryoprobes and 15 per patient for documentation and additional histological slides

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2012	29/12/2020	Yes	No

Editorial Notes

29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.