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Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Biopsy Diagnosing Peripheral Pulmonary Lesions

NCT07772479

Enrolling By InvitationNA

Sponsor: Beijing Chao Yang Hospital

Conditions: Peripheral Pulmonary Lesions (PPLs), Pulmonary Nodules

Interventions: CassiII rotational core biopsy, Automated biopsy

Countries: China

This study aims to systematically compare the diagnostic efficacy, specimen quality, and complication rates of the cryobiopsy needle technique（CassiII rotational core biopsy） versus the automated biopsy technique in the biopsy of pulmonary nodules, thereby providing a reliable evidentiary basis for clinical practice.

Eligibility overview

Sex: ALL

Age: 18 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* If a chest CT scan reveals pulmonary nodules with an unknown nature, a biopsy is required for definitive diagnosis; if the chest CT shows multiple pulmonary nodules, one of these nodules should be selected as the target lesion;

  * Axial chest CT imaging demonstrates peripheral pulmonary nodules located in the pulmonary region, with diameters ranging from 8 mm to 30 mm; ③Voluntarily undergo CT-guided lung puncture biopsy and meet all preoperative requirements; ④Participants demonstrate good compliance, are able to cooperate with the study observations, are fully informed about the study's objectives and methods, acknowledge the potential risks, agree to participate in the study, and sign the informed consent form.

Exclusion Criteria:

* Severe cardiopulmonary dysfunction;

  * Irreversible coagulation disorders;

    * Suspected vascular lesions or arteriovenous malformations (assessed by contrast-enhanced CT), or presence of bronchial artery penetration at the planned biopsy site, or suspected pulmonary metastasis from renal cell carcinoma, indicating a high risk of hemorrhage;

      * PET-CT findings indicate a malignant pulmonary nodule; surgical evaluation may prioritize surgical intervention for the patient;

        * Pregnant or lactating women; ⑥ Patients with psychiatric disorders or those unable to cooperate during the puncture procedure; ⑦ Presence of anesthesia contraindications; allergy to anesthetic agents; or a history of multiple severe allergies or hereditary allergies;

          * If the participant has participated in other studies within the past three months without withdrawing or completing those studies, this will affect the observation of the present study; ⑨ Refusal to participate in this study, unwillingness to accept the follow-up protocol, or other circumstances in which the investigator deems the participant unsuitable for participation in this study.

Locations (1)

Beijing, Chaoyang, China