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

NCT07772479 | Enrolling By Invitation DMC

• 1 other identifier: 2025-ke-1100-1
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief Summary

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

Peripheral Pulmonary Lesions (PPLs); Pulmonary Nodules

Keywords

Rotational Cryobiopsy Needle; Automated Biopsy Needle; Diagnostic Yield; Peripheral Pulmonary Lesions

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of the two biopsy methods

  Diagnostic yield = (Number of pathologically positive cases / Total number of enrolled cases) × 100%

  From enrollment to the end of procedure at 2 years

Secondary Outcomes (3)

• Specimen size

  From enrollment to the end of procedure at 2 years

• Consistency analysis between AI-ROSE results and pathological results

  From enrollment to the end of procedure at 2 years

• Safety indicators

  From enrollment to the end of procedure at 2 years

Study Arms (2)

CassiII rotational core biopsy group

EXPERIMENTAL

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 Subsequently, the CassiII rotational core biopsy needle and the coaxial needle are withdrawn sequentially.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.

Procedure: CassiII rotational core biopsy

Automated biopsy needle group

ACTIVE COMPARATOR

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.

Procedure: Automated biopsy

Interventions

CassiII rotational core biopsy PROCEDURE

CassiII rotational core biopsy needle is inserted in lesion site, ≥1 biopsy is performed.

CassiII rotational core biopsy group

Automated biopsy PROCEDURE

Automated biopsy needle is inserted in lesion site, ≥1 biopsy is performed.

Automated biopsy needle group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Chaoyang, 100020, China

Location

Related Publications (15)

• Xie 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 RESULT

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• Tai 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 RESULT

• Vachani 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 RESULT

• Yoon 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 RESULT

• Balasubramanian 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.

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• Tomiyama N, Yasuhara Y, Nakajima Y, Adachi S, Arai Y, Kusumoto M, Eguchi K, Kuriyama K, Sakai F, Noguchi M, Murata K, Murayama S, Mochizuki T, Mori K, Yamada K. CT-guided needle biopsy of lung lesions: a survey of severe complication based on 9783 biopsies in Japan. Eur J Radiol. 2006 Jul;59(1):60-4. doi: 10.1016/j.ejrad.2006.02.001. Epub 2006 Mar 10.

  PMID: 16530369 RESULT

• Wiener RS, Schwartz LM, Woloshin S, Welch HG. Population-based risk for complications after transthoracic needle lung biopsy of a pulmonary nodule: an analysis of discharge records. Ann Intern Med. 2011 Aug 2;155(3):137-44. doi: 10.7326/0003-4819-155-3-201108020-00003.

  PMID: 21810706 RESULT

• Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017 Jan;27(1):138-148. doi: 10.1007/s00330-016-4357-8. Epub 2016 Apr 23.

  PMID: 27108299 RESULT

• Huo YR, Chan MV, Habib AR, Lui I, Ridley L. Pneumothorax rates in CT-Guided lung biopsies: a comprehensive systematic review and meta-analysis of risk factors. Br J Radiol. 2020 Apr 1;93(1108):20190866. doi: 10.1259/bjr.20190866. Epub 2020 Jan 3.

  PMID: 31860329 RESULT

• Tachibana K, Nakazato Y, Tsuchida S, Kazama T, Minato K, Yoshida T, Fujita A, Horikoshi H, Tanaka R, Iijima M, Goya T. Immediate cytology improves accuracy and decreases complication rate in real-time computed tomography-guided needle lung biopsy. Diagn Cytopathol. 2013 Dec;41(12):1063-8. doi: 10.1002/dc.22940. Epub 2012 Dec 14.

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• Yamagami T, Yoshimatsu R, Miura H, Yamada K, Takahata A, Matsumoto T, Hasebe T. Diagnostic performance of percutaneous lung biopsy using automated biopsy needles under CT-fluoroscopic guidance for ground-glass opacity lesions. Br J Radiol. 2013 Feb;86(1022):20120447. doi: 10.1259/bjr.20120447.

  PMID: 23385998 RESULT

• Zhang L, Shi L, Xiao Z, Qiu H, Peng P, Zhang M. Coaxial technique-promoted diagnostic accuracy of CT-guided percutaneous cutting needle biopsy for small and deep lung lesions. PLoS One. 2018 Feb 15;13(2):e0192920. doi: 10.1371/journal.pone.0192920. eCollection 2018.

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• Kothary N, Lock L, Sze DY, Hofmann LV. Computed tomography-guided percutaneous needle biopsy of pulmonary nodules: impact of nodule size on diagnostic accuracy. Clin Lung Cancer. 2009 Sep;10(5):360-3. doi: 10.3816/CLC.2009.n.049.

  PMID: 19808195 RESULT

• Yeow KM, Tsay PK, Cheung YC, Lui KW, Pan KT, Chou AS. Factors affecting diagnostic accuracy of CT-guided coaxial cutting needle lung biopsy: retrospective analysis of 631 procedures. J Vasc Interv Radiol. 2003 May;14(5):581-8. doi: 10.1097/01.rvi.0000071087.76348.c7.

  PMID: 12761311 RESULT

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study employed a prospective, randomized, single-blind, parallel-group, single-center trial design, enrolling consecutive patients with peripheral pulmonary nodules of unknown etiology. The subjects were randomly assigned (1:1) to either the CassiII rotational core biopsy group (experimental group) or the automated biopsy needle group (control group).

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 19, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)