Clinical trial · Interventional
Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Biopsy Diagnosing Peripheral Pulmonary Lesions
Comparative Study of Rotational Cryobiopsy Needle and Automated Biopsy Needle in Transthoracic Needle Biopsy for the Diagnosis of Peripheral Pulmonary Lesions
NCT07772479CI-TRIAL-00122690enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral Pulmonary Lesions (PPLs) | — | UNRESOLVED | — |
| Pulmonary Nodules | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated biopsy | Procedure | — | UNRESOLVED |
| CassiII rotational core biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CassiII rotational core biopsy group
- description
- Under CT guidance, a percutaneous puncture is performed using a coaxial needle; upon reaching the target lesion, the CassiII rotational core biopsy needle is inserted along the coaxial needle for biopsy. At the same lesion site, ≥1 biopsy is performed; depending on sample adequacy, the maximum number of biopsies shall not exceed 3, with at least 1 tissue specimen obtained from each biopsy. Subsequently, the CassiII rotational core biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax.
- interventionNames
- Procedure: CassiII rotational core biopsy
- type
- ACTIVE_COMPARATOR
- label
- Automated biopsy needle group
- description
- Under CT guidance, a coaxial needle is percutaneously inserted; upon reaching the target lesion, an automated biopsy needle is advanced along the coaxial needle and activated. Biopsy is performed at least once at the same lesion site; depending on sample adequacy, the procedure may be repeated up to a maximum of 3 times, with at least one tissue specimen obtained from each attempt. Subsequently, the automated biopsy needle and the coaxial needle are withdrawn sequentially. After resting for 5-10 minutes, a repeat CT scan is performed to assess for any complications such as hemorrhage or pneumothorax.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.References
Publications (15)
- RESULTXie S, Ju S, Zhang X, Qi C, Zhang J, Mao M, Chen C, Chen Y, Ji F, Zhou J, Wang L. A retrospective comparative study on the diagnostic efficacy and the complications: between CassiII rotational core biopsy and core needle biopsy. Front Oncol. 2023 Sep 26;13:1067246. doi: 10.3389/fonc.2023.1067246. eCollection 2023. PMID 37823052
- RESULTYeow KM, Su IH, Pan KT, Tsay PK, Lui KW, Cheung YC, Chou AS. Risk factors of pneumothorax and bleeding: multivariate analysis of 660 CT-guided coaxial cutting needle lung biopsies. Chest. 2004 Sep;126(3):748-54. doi: 10.1378/chest.126.3.748. PMID 15364752
- RESULTTai R, Dunne RM, Trotman-Dickenson B, Jacobson FL, Madan R, Kumamaru KK, Hunsaker AR. Frequency and Severity of Pulmonary Hemorrhage in Patients Undergoing Percutaneous CT-guided Transthoracic Lung Biopsy: Single-Institution Experience of 1175 Cases. Radiology. 2016 Apr;279(1):287-96. doi: 10.1148/radiol.2015150381. Epub 2015 Oct 19. PMID 26479161
- RESULTVachani A, Zhou M, Ghosh S, Zhang S, Szapary P, Gaurav D, Kalsekar I. Complications After Transthoracic Needle Biopsy of Pulmonary Nodules: A Population-Level Retrospective Cohort Analysis. J Am Coll Radiol. 2022 Oct;19(10):1121-1129. doi: 10.1016/j.jacr.2022.04.010. Epub 2022 Jun 20. PMID 35738412
- RESULTYoon SH, Park CM, Lee KH, Lim KY, Suh YJ, Im DJ, Hur J, Han DH, Kang MJ, Choo JY, Kim C, Kim JI, Hong H. Analysis of Complications of Percutaneous Transthoracic Needle Biopsy Using CT-Guidance Modalities In a Multicenter Cohort of 10568 Biopsies. Korean J Radiol. 2019 Feb;20(2):323-331. doi: 10.3348/kjr.2018.0064. PMID 30672172
- RESULTBalasubramanian P, Abia-Trujillo D, Barrios-Ruiz A, Garza-Salas A, Koratala A, Chandra NC, Yu Lee-Mateus A, Labarca G, Fernandez-Bussy S. Diagnostic yield and safety of diagnostic techniques for pulmonary lesions: systematic review, meta-analysis and network meta-analysis. Eur Respir Rev. 2024 Sep 18;33(173):240046. doi: 10.1183/16000617.0046-2024. Print 2024 Jul.