Evaluate the Diagnostic Value of Puncture Biopsy for PPL Under the Guidance of Navigation and Radial EBUS: a Real-World Study

• Conditions: Lung; Nodes

• Registration Number: NCT04692038
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief Summary

The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound (r-EBUS), and to explore the factors influencing the diagnosis rate.

Detailed Description

The study will last for no longer than 12 months. Patients will be first screened, and only after meeting all the inclusion criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules. The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy. The secondary endpoints include the success rate of biopsy, the operation time of the bronchoscope and so on.

Study Timeline

• Study First Submitted: 2020-12-29
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-04
• Last Update Posted: 2021-01-06
• Study Start: 2021-01-10
• Primary Completion: 2021-12-20
• Study Completion: 2022-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1. Age ≥ 18 years old; 2. Chest CT shows that the peripheral lung noduleswith uncertain diagnosis are adjacent or far from the airway, and/or are difficult to obtain samples by routine biopsy as assessed by investigators; 3. Understand the research and sign the informed consent form.

Exclusion Criteria

• 1. Contraindications for bronchoscopy; 2. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery; 3. Bronchoscopy shows visible intra-airway nodules above the 3rd bronchus; 4. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Combined Diagnostic yield	Six months	Diagnostic yield is defined as the proportion of nodules diagnosed by combined technologies in all nodulesundergoing bronchoscopy biopsy.

Secondary Outcome Measures

Name	Time	Method
The success rate of biopsy	Immediately after bronchoscopy biopsy	The success rate of biopsy is defined as the number of nodules with at least one qualified abnormal lung tissue that can be used for pathological diagnosis divided by the number of all nodules diagnosed by combined technologies.
Diagnostic yield	Six months	Diagnostic yield is defined as the proportion of nodulesdiagnosed by forceps biopsy (or puncture biopsy) in all nodulesundergoing bronchoscopy biopsy.
Operation time of the bronchoscopy	Immediately after bronchoscopy biopsy	The operation time of the bronchoscopy is defined as the total time from insertion of the bronchoscope to withdrawal of the bronchoscope.

Trial Locations

Locations (1)

Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China