EBUS-Miniprobes Sampling for Peripheral Lung Lesions

NCT ID: NCT03422744

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-03
• Study Completion Date: 2022-09-30

Brief Summary

There is an interest in characterazing asymptomatic peripheral lung lesions beacause they could be an early form of neoplasm.

These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.

The trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes can be used to collect tissue sample.

When no diagnosis is made with this technique, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).

In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.

People presenting with a peripheral lung lesion, invisible with a classical endoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.

If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.

If there isn't a diagnosis after this first exam, a second exam will be proposed to the participants including an histologic smear, a trans bronchial biopsy and a fine needle aspiration under fluoroscopic guidance.

Detailed Description

Because of the more frequent use of thoracic imaging by ct-scan, there are a growing number of asymptomatic peripheral lung lesions that are revealed.

As they could be a be an early form of pulmonary neoplasm, it is important for the patient that a definitive diagnosis is made.

These lesions are invisible in the endoscopic exam, so the samples must be made with a guiding technique.

The first guided technique was the biopsy under fluoroscopic control. During the last decade, several other technique have been developed.

Among them is the trans bronchial biopsy after tracking by radial echo-endoscopic miniprobes. This technique has the advantage of needing no exposition to ionizing radiation and lower the risk of pneumothorax, comparing with transthoracic ponction.

In a study made by Guvenc and al. in 2015 this technique achieves a diagnostic in 62 % of the cases.

When the result is negative, the attitude can be discussed between different option: follow up versus an other sampling technique (transthoracic ponction, surgery,...).

In this study the investigators will study the interest of a sampling guided by fluoroscopy after a negative sampling guided by radial echo-endoscopic miniprobe.

Patients presenting with a peripheral lung lesion, invisible with a classical bronchoscopy, will be included after they sign an informed consent. The bronchoscopy will be executed after a local anesthesia and if there are no visible endobronchial lesions, the radial EBUS mini-probe will be used.

If the lesion is spotted, the probe will be withdrawn until the most distal visible carena and the withdrawal distance will be mesured. The biospy forceps will then be introduce at the same distance from this carena and at least five biopsy will be taken.

If these samples give an anatomopathologic diagnosis consistent with the clinical context, no other exam will be proposed.

If there isn't a diagnosis after this first exam, a second exam will be proposed to the participant including an histologic smear, a transbronchial biopsy and a fine needle aspiration under fluoroscopic guidance.

If there is still no diagnosis after this second exam, the attitude will be discussed case by case between a follow up and an other invasive diagnosis mean (transthoracic punction under ct scan control, surgery,…).

Conditions

Lung Cancer; Peripheral Pulmonary Lesions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patient with peripheral lung lesion

Patient presenting a peripheral lung lesion seen at Ct-scan but invisible at simple endoscopy.

Intervention : trans bronchial biopsy guided by echo-endoscopic miniprobes.

Intervention: If first intervention doesn't give a diagnosis we get cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control

Group Type: EXPERIMENTAL

trans bronchial biopsy guided by echo-endoscopic miniprobes

Intervention Type: PROCEDURE

We get a sample trough transbronchial biopsy guided by echo-endoscopic miniprobe.

if first one negative: samples under fluoroscopic control

Intervention Type: PROCEDURE

If no diagnosis with first intervention we get a second sample by cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control

Interventions

trans bronchial biopsy guided by echo-endoscopic miniprobes

We get a sample trough transbronchial biopsy guided by echo-endoscopic miniprobe.

Intervention Type: PROCEDURE

if first one negative: samples under fluoroscopic control

If no diagnosis with first intervention we get a second sample by cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients presenting a peripheral lung lesion having given their approval

Exclusion Criteria

• Lung lesion who according to ct Scan has a greater diameter lesser than 10 mm
• Ground glass lesion
• Lesion that are suspected to be a bronchopneumonia
• Contra-indication for endoscopic exam ( uncontrolled hypoxia, hypercapnia, sympotmatic bronchial hyperreactivity, recent myocardial infarction, heart failure)
• contra-indication for a transbronchial biopsy ( coagulapathy iatrogenic or not, recent uptake of anitaggregant medicines)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Marie Bruyneel

Principal investigator, pneumology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marie Bruyneel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU St Pierre

Locations

CHu Saint Pierre

Brussels, , Belgium

Countries

Belgium

Related Links

https://www.ncbi.nlm.nih.gov/pubmed/23728872

Endobronchial ultrasound in the management of nonsmall cell lung cancer

http://www.jto.org/article/S1556-0864%2815%2931655-5/fulltext

Computed Tomography Characteristics Predictive for Radial EBUS-Miniprobe-Guided Diagnosis of Pulmonary Lesions

http://www.jto.org/article/S1556-0864%2815%2931500-8/fulltext

Use of Fluoroscopy During Endobronchial Ultrasonography for Transbronchial Lung Biopsies of Peripheral Lung Lesions

http://www.archbronconeumol.org/en/endobronchial-ultrasound-for-diagnosis-peripheral/articulo/S1579212914001049/

Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions. A Controlled Study With Fluoroscopy

Other Identifiers

B076201733056

Identifier Type: -

Identifier Source: org_study_id