The Study of ENB With Ultra-thin Cryobiopsy in the Diagnosis of Peripheral Pulmonary Nodules

Официальное название

The Comparative Study of Electromagnetic Navigation Bronchoscopic With Ultra-thin Cryobiopsy and Forceps Biopsy in the Diagnosis of Peripheral Pulmonary Nodules

Обзор

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

Подробное описание

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

Вмешательства

• Процедура Cryobiopsy
  Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.
• Процедура Forceps biopsy
  Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.

Первичные конечные точки

• Diagnostic yield [Срок оценки: follow-up for 12 months]

Вторичные конечные точки (1)

• Adverse events [Срок оценки: follow-up for one month]

Критерии участия

Критерии включения

• age 18 to 90 years;
• pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy;
• chest CT showed that the nodule was located in the segmental bronchus and below, and the maximum diameter of the nodule was 8 mm to 30 mm.It was not accessible by conventional bronchoscopy;
• if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion.

Критерии исключения

• contraindications to the bronchoscopy procedure;
• high risk of bleeding, such as bronchial artery penetration or suspected lung metastasis of renal cell carcinoma;
• electromagnetic source implanted in the body;
• contraindications to anesthesia;
• pregnant woman;
• participated in other studies within three months and did not withdraw or finish, affect the observation of this study;
• inability or unwillingness to provide informed consent or comply with the follow-up schedule.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Beijing Chaoyang Hospital — Пекин

Публикации

• 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. PMID 39293856
• 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. PMID 37914556
• 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. PMID 33902504
• 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. PMID 34022184
• 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. PMID 35000601
• 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 202 PMID 37379810
• 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. PMID 38379178
• 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. PMID 37380091

Идентификаторы

NCT: NCT07326072 · MR-11-25-060861

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗