Condition category
Cancer
Date applied
01/12/2009
Date assigned
19/01/2010
Last edited
19/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.uni-tuebingen.de/uni/qvr/e-30/m30-01.html

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes