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To investigate the safety and efficacy of ultrafine cryoprobe biopsy by electromagnetic navigation bronchoscopy compared with biopsy forceps in the diagnosis of peripheral pulmonary nodules in a national multicenter randomized controlled trial
This project intends to carry out a national multicenter randomized controlled study, with traditional forceps biopsy as the control group and cryobiopsy as the experimental group, to verify the feasibility, effectiveness and safety of electromagnetic navigation bronchoscope-guided cryobiopsy in the diagnosis of peripheral pulmonary nodules, so as to provide an efficient and minimally invasive diagnostic method for the diagnosis of peripheral pulmonary nodules
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryobiopsy group | Experimental | Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy |
|
| Forceps biopsy group | Active Comparator | Electromagnetic Navigation Bronchoscopic with Forceps Biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryobiopsy | Procedure | Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield | The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions | follow-up for 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events related to the research | follow-up for one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feng Wang, Doctor | Beijing Chaoyang Hospital, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39293856 | 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. | |
| 37914556 |
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We will share clinical date.
Data will be available for sharing for 2 years after formal publication of the study.
Researchers working on cryobiopsy and electromagnetic navigation bronchoscopy.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 7, 2025 | Jan 11, 2026 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 7, 2025 | Jan 11, 2026 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The subjects were randomly (1:1) divided into groups. Cryobiopsy was assigned to the experimental group, while biopsy using a biopsy forceps was assigned to the control group.
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| Forceps biopsy | Procedure | Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping. |
|
| Tang Y, Tian S, Chen H, Li X, Pu X, Zhang X, Zheng Y, Li Y, Huang H, Bai C. Transbronchial lung cryobiopsy for peripheral pulmonary lesions. A narrative review. Pulmonology. 2024 Sep-Oct;30(5):475-484. doi: 10.1016/j.pulmoe.2023.08.010. Epub 2023 Oct 31. |
| 33902504 | Result | Bondue B, Schlossmacher P, Allou N, Gazaille V, Taton O, Gevenois PA, Vandergheynst F, Remmelink M, Leduc D. Trans-bronchial lung cryobiopsy in patients at high-risk of complications. BMC Pulm Med. 2021 Apr 26;21(1):135. doi: 10.1186/s12890-021-01503-9. |
| 34022184 | Result | Matsumoto Y, Nakai T, Tanaka M, Imabayashi T, Tsuchida T, Ohe Y. Diagnostic Outcomes and Safety of Cryobiopsy Added to Conventional Sampling Methods: An Observational Study. Chest. 2021 Nov;160(5):1890-1901. doi: 10.1016/j.chest.2021.05.015. Epub 2021 May 19. |
| 35000601 | Result | Nakai T, Watanabe T, Kaimi Y, Ogawa K, Matsumoto Y, Sawa K, Okamoto A, Sato K, Asai K, Matsumoto Y, Ohsawa M, Kawaguchi T. Safety profile and risk factors for bleeding in transbronchial cryobiopsy using a two-scope technique for peripheral pulmonary lesions. BMC Pulm Med. 2022 Jan 10;22(1):20. doi: 10.1186/s12890-021-01817-8. |
| 37379810 | Result | Nakai T, Watanabe T, Kaimi Y, Shiomi K, Ando K, Miyamoto A, Ogawa K, Matsumoto Y, Sawa K, Sato K, Asai K, Matsumoto Y, Mikami Y, Ohsawa M, Kawaguchi T. Diagnostic Utility and Safety of Non-Intubated Cryobiopsy Technique Using a Novel Ultrathin Cryoprobe in Addition to Conventional Biopsy Techniques for Peripheral Pulmonary Lesions. Respiration. 2023;102(7):503-514. doi: 10.1159/000531010. Epub 2023 Jun 28. |
| 38379178 | Result | Kim MH, Kim SH, Lee G, Mok J, Lee MK, Song JS, Eom JS. Next-generation sequencing using tissue specimen collected with a 1.1 mm-diameter cryoprobe in patients with lung cancer. Respirology. 2024 Apr;29(4):333-339. doi: 10.1111/resp.14680. Epub 2024 Feb 20. |
| 37380091 | Result | Kim SH, Mok J, Kim S, Yoo WH, Jo EJ, Kim MH, Lee K, Kim KU, Park HK, Lee MK, Eom JS. Clinical outcomes of transbronchial cryobiopsy using a 1.1-mm diameter cryoprobe for peripheral lung lesions - A prospective pilot study. Respir Med. 2023 Oct;217:107338. doi: 10.1016/j.rmed.2023.107338. Epub 2023 Jun 26. |