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

A Real-World Study to Evaluate the Diagnostic Value of Puncture Biopsy for Peripheral Lung Nodules Under the Guidance of Augmented Reality Navigation System Combined With Radial EBUS

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.

Study Overview

• Status: Unknown
• Conditions: Lung; Nodes
• Intervention / Treatment: Device: Forceps biopsy combined with puncture biopsy under the guidance of Augmented Reality Navigation and Radial EBUS

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet all inclusion criteria and do not meet any exclusion criteria will be enrolled in the study consecutively.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Treatment Group; The subjects would receive forceps biopsy combined with puncture biopsy under the guidance of Augmented Reality Navigation and Radial EBUS

Device: Forceps biopsy combined with puncture biopsy under the guidance of Augmented Reality Navigation and Radial EBUS; During the operation, under the guidance of Augmented Reality Navigation, the bronchoscope will reach the location of the target pulmonary nodules, and the EBUS probe will be inserted through the bronchoscope working channel, and gradually approach the target nodules to obtain EBUS images. After typical EBUS images are observed and the location is confirmed, the EBUS probe will be withdrawn and biopsy forceps and puncture biopsy needle will be used to obtain samples at the target locations respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combined Diagnostic yield	Diagnostic yield is defined as the proportion of nodules diagnosed by combined technologies in all nodulesundergoing bronchoscopy biopsy.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic yield	Diagnostic yield is defined as the proportion of nodulesdiagnosed by forceps biopsy (or puncture biopsy) in all nodulesundergoing bronchoscopy biopsy.	Six months
The success rate of 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.	Immediately after bronchoscopy biopsy
Operation time of the bronchoscopy	The operation time of the bronchoscopy is defined as the total time from insertion of the bronchoscope to withdrawal of the bronchoscope.	Immediately after bronchoscopy biopsy

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease

Study record dates

Study Major Dates

• Study Start (Anticipated): January 10, 2021
• Primary Completion (Anticipated): December 20, 2021
• Study Completion (Anticipated): March 20, 2022

Study Registration Dates

• First Submitted: December 29, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: biopsy; Peripheral pulmonary nodules
• Other Study ID Numbers: 20201215

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No