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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-05

Study Completion Date

2027-07-31

Brief Summary

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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

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Detailed Description

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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

Conditions

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Diagnosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cryobiopsy group

Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy

Group Type EXPERIMENTAL

Cryobiopsy

Intervention Type PROCEDURE

Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.

Forceps biopsy group

Electromagnetic Navigation Bronchoscopic with Forceps Biopsy

Group Type ACTIVE_COMPARATOR

Forceps biopsy

Intervention Type PROCEDURE

Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.

Interventions

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Cryobiopsy

Cryobiopsy : Insert a 1.1mm cryoprobe along the electromagnetic navigation catheter, obtain samples with at least 2 pieces each.

Intervention Type PROCEDURE

Forceps biopsy

Forceps biopsy:Insert 1.8mm forceps along the electromagnetic navigation catheter, obtain at least five tissue samples through precise clamping.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. age 18 to 90 years;
2. pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy;
3. 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;
4. if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No