Confocal Laser Endomicroscopy Guided Cryobiopsy in the Diagnosis of Interstitial Lung Disease

NCT ID: NCT06741826

Last Updated: 2024-12-19

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-12-31

Brief Summary

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A prospective multicenter randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of NCLE-NB-Rebus-guided peripheral pulmonary nodule biopsy, and to compare the diagnostic efficacy and safety of biopsy forceps biopsy and needle aspiration biopsy in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS.

Detailed Description

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A prospective, multicenter, randomized controlled trial was conducted to evaluate the diagnostic efficacy and safety of nCLE-NB-rEBUS guided peripheral pulmonary nodule biopsy. Patients with peripheral pulmonary nodules suspected of lung cancer and pulmonary tuberculosis were enrolled to sign informed consent. Subjects were randomized to the nCLE-NB-rEBUS Group (Group A) or the NB-rEBUS Group (Group B) subgroup (1:1 ratio) according to the random number table, and subjects randomly assigned to Group A or Group B were again randomized to the biopsy forceps subgroup or biopsy needle subgroup by the random number table. The diagnostic efficacy and safety of the NCLE-NB-REbus group and the NB-rEBUS group were compared to evaluate whether nCLE could improve the diagnostic rate of NB-REbus-guided peripheral pulmonary nodule biopsy. The diagnostic efficacy and safety of using biopsy forceps and biopsy needle in peripheral pulmonary nodule biopsy guided by nCLE-NB-rEBUS were compared to determine the reasonable biopsy method.

Conditions

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Solitary Pulmonary Nodule Multiple Pulmonary Nodule

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group nCLE-NB-rEBUS

According to the preoperative planning, the bronchoscope was placed at the bronchial opening of the target lobe segment, and the catheter was operated to reach the target lesion under the guidance of virtual navigation and after reaching the target lesion, the ultrasonic probe was opened to observe whether the ultrasonic image of the target lesion could be detected, and the image recording was collected to confirm that the virtual navigation catheter had accurately reached the target lesion. The ultrasound probe was removed, the TX ™ disposable transbronchoscopic dilator catheter was inserted to establish a working channel, and the nCLE was inserted to probe the benign and malignant status of the pleural lesion to determine the biopsy location and image recording was taken. Then the biopsy equipment was inserted and delivered to the target lesion for biopsy, and 5 pieces of biopsy tissue were collected.

Group Type EXPERIMENTAL

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Intervention Type PROCEDURE

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Group NB-rEBUS

After anesthesia, electronic bronchoscope was inserted through laryngeal mask/tracheal intubation for routine bronchoscopy. According to the preoperative planning, the bronchoscope was placed at the bronchial opening of the target lobe segment, and the catheter was operated to reach the target lesion under the guidance of virtual navigation, and was placed about 1 cm away from the target. The radial ultrasonic probe was implanted, and after reaching the target lesion, the ultrasonic probe was opened to observe whether the ultrasonic image of the target lesion could be detected, and the image recording was collected to confirm that the virtual navigation catheter had accurately reached the target lesion. Take out the ultrasonic probe, insert it into the biopsy equipment, deliver it to the target lesion for biopsy, and collect 5 pieces of biopsy tissue.

Group Type EXPERIMENTAL

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Intervention Type PROCEDURE

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Interventions

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Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy under needle-based confocal laser endomicroscopy.

Intervention Type PROCEDURE

Other Intervention Names

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Navigation bronchoscopy combined with radial endobronchial ultrasound guided pulmonary nodule biopsy.

Eligibility Criteria

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Inclusion Criteria

* Patients with peripheral pulmonary nodules suspected of lung cancer by CT examination
* Patients who intend to undergo a bronchoscopic lung biopsy to determine benign or malignant pulmonary nodules;
* Age ≥18 years
* Sign informed consent.

Exclusion Criteria

* There is an uncorrectable coagulation disorder or anticoagulation therapy that cannot be stopped before surgery;
* Tumors can be seen in the bronchus
* Hemodynamic instability;
* Refractory hypoxemia;
* Patients with pregnant and lactating patients
* Any illness or condition that interferes with the completion of the initial or subsequent assessment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gang Hou

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Gang Hou

Role: CONTACT

Phone: 13840065481

Email: [email protected]

Other Identifiers

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2022YFC2404404-1

Identifier Type: -

Identifier Source: org_study_id