The Diagnostic Yield and Safety of Transbronchial Cryobiopsy in The Pulmonary Periphral Nodule

The Diagnostic Yield and Safety of Transbronchial Cryobiopsy Under The Guidance of The Endobronchial Ultrasound in The Pulmonary Periphral Nodule: A Multicenter Prospective Random Control Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04661956

Enrollment

300

Registered

2020-12-10

Start date

2020-12-15

Completion date

2022-06-15

Last updated

2021-10-15

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

Conditions

Complication Rate, Diagnosis

Keywords

Transbronchial Cryobiopsy, Diagnostic Yield, Safety, Pulmonary Periphral Nodule

Brief summary

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety.

Detailed description

Transbronchial cryobiopsy under the guidance of endobronchial ultrasound is performed in patients with pulmonary peripheral nodule, and assess the diagnostic yield and safety. This is a multi-center prospective randomized control trial.

Interventions

PROCEDURETransbronchial cryobiopsy/Transbronchial lung biopsy (forcep)

Transbronchial lung biopsy by cryoprobe or by forcep

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

a prospective multicenter random control trial

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. The patients are admitted as Pulmonary Periphral Nodule, while undefined after thorough history collection, laboratory examination and radiological data. 2. The longest diameter of the Pulmonary Periphral Nodule is less than 30mm in HRCT. 3. The Pulmonary Periphral Nodule can be detected by radial-EBUS 4. Transbronchial cryobiopsy(TBCB) is indicated by clinicians for definitive diagnosis and patients are content with the examination with agreement signed. 5. Routine blood test, ECG examination, coagulation function, chest HRCT have been completed.

Exclusion criteria

1. The longest diameter of the Pulmonary Periphral Nodule is more than 30mm. 2. The Pulmonary Periphral lesions cannot be detected by the radial endobronchial ultrasound. 3. The clinical examinations mentioned above are not completed. The patient cannot endure or does not agree the procedure

Design outcomes

Primary

Measure	Time frame	Description
Diagnotic yield	six months	Percentage of definitive pathological diagnosis by transbronchial cryobiopsy

Secondary

Measure	Time frame	Description
Complication rate	one week	Incidence of bleeding, pneumothorax (during the procedure and within 7 days after the intervention

Countries

China

Contacts

Primary ContactXiaobo Chen, Doctor

xiaobo-win@163.com+8613751721744

Backup ContactShiyue Li, master

lishiyue@188.com8620-83062896

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026