EBUS-Miniprobes Sampling for Peripheral Lung Lesions

NCT03422744 | Terminated

• 1 other identifier: B076201733056
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Peripheral Pulmonary Lesions

Outcome Measures

Primary Outcomes (1)

• Percentage Definitive anatomopathological diagnosis

  Percentage Definitive anatomopathological diagnosis obtained via the pathological exam of microscopic evaluation, immunostaining and/ or molecular analysis)

  1 week

Study Arms (1)

patient with peripheral lung lesion

EXPERIMENTAL

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

Procedure: trans bronchial biopsy guided by echo-endoscopic miniprobes; Procedure: if first one negative: samples under fluoroscopic control

Interventions

trans bronchial biopsy guided by echo-endoscopic miniprobes PROCEDURE

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

patient with peripheral lung lesion

if first one negative: samples under fluoroscopic control PROCEDURE

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

patient with peripheral lung lesion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting a peripheral lung lesion having given their approval

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHu Saint Pierre

Brussels, 1000, Belgium

Location

Related Links

• Endobronchial ultrasound in the management of nonsmall cell lung cancer
• Computed Tomography Characteristics Predictive for Radial EBUS-Miniprobe-Guided Diagnosis of Pulmonary Lesions
• Use of Fluoroscopy During Endobronchial Ultrasonography for Transbronchial Lung Biopsies of Peripheral Lung Lesions
• Endobronchial Ultrasound for the Diagnosis of Peripheral Pulmonary Lesions. A Controlled Study With Fluoroscopy

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marie Bruyneel, MD PhD

  CHU St Pierre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, pneumology

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: February 6, 2018
• Study Start: August 3, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

BE (1)