Comparison of forceps biopsy and cryobiopsy in bronchoscopically visible pulmonary lesions

Randomised prospective controlled study for the comparison of forceps biopsy and cryobiopsy in bronchoscopically visible pulmonary lesions

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN97376650

Enrollment

600

Registered

2010-01-19

Start date

2005-06-01

Completion date

Unknown

Last updated

2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchoscopically visible pulmonary lesions Cancer Malignant neoplasm of other and ill-defined sites in the respiratory system and intrathoracic organs

Interventions

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 usi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026