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Evaluation of the Efficacy and Safety of Endobronchial Ultrasound-Guided Biopsy Using a Cryoprobe

EBUS-Cryo study

Koichi Goto

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa Chiba 277-8577, Japan

kgoto@east.ncc.go.jp

Sakai Tetsuya

National Cancer Center Hospital East

6-5-1, Kashiwanoha, Kashiwa Chiba 277-8577, Japan

+81-471331111

tetsakai@east.ncc.go.jp

Recruiting

May. 08, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

1) Patients suspected of having primary lung cancer based on chest CT or those already diagnosed with primary lung cancer.
2) Patients with apparent suspected lymph node metastasis of lung cancer, presenting with mediastinal or hilar lymphadenopathy that meets at least one of the following criteria (Short-axis diameter of >10 mm on chest CT, FDG accumulation with SUV-max >2.5 on PET-CT, These patients require a tissue biopsy via EBUS-TBNA). (Patients requiring differentiation of lymph node metastasis presence or absence are excluded.)
3) Patients aged 18 years or older at the time of consent.
4) Patients with an ECOG performance status (PS) of 0, 1, or 2.
5) Patients without severe dysfunction of major organs (bone marrow, heart, lungs, liver, kidneys, etc.), meeting the following criteria:
White blood cell count >3,000 /mm3
Neutrophil count > 1,500 /mm3
Hemoglobin > 9.0 g/dL
Platelet count > 100,000 /mm3
PaO2 > 60 torr or SpO2 > 90%
6) Patients with preserved coagulation function sufficient to tolerate bronchoscopy.
7) Patients who have received a thorough explanation of the study and have provided written informed consent.

1) Patients requiring EBUS-TBNA for multiple lymph nodes.
2) Patients with hypersensitivity to lidocaine, midazolam, flumazenil, or pethidine hydrochloride, or those with severe hypersensitivity to other drugs.
3) Patients receiving antiplatelet or anticoagulant therapy. (Patients may be included if an appropriate withdrawal period is observed.)
4) Patients requiring EBUS-TBNA for lymph nodes with apparent invasion into the hilar vessels, heart, or major blood vessels on imaging.
5) Patients with severe comorbidities (such as heart disease, interstitial pneumonia, or uncontrolled hypertension).
6) Patients with clinically significant infections.
7) Pregnant, lactating, or potentially pregnant patients.
8) Patients deemed unsuitable for safe participation in this study by the attending physician.

Both

Lung Cancer

Multiple EBUS-Cryobiopsies will be performed after EBUS-TBNA

Lung Cancer

EBUS-TBNA, EBUS-Cryo

D008175

The proportion of tissue samples containing malignant tumor cells.

Incidence rate of adverse events
Rate of histological confirmation
Specimen size (long diameter, short diameter, area, tumor cell ratio) in thin-section slides prepared from pathological samples
Proportion of tissue samples containing malignant tumor cells among all collected specimens

+81-4-7133-1111

April. 10, 2025

No

none