Clinical trial NCT03422744: EBUS-Miniprobes Sampling for Peripheral Lung Lesions
Official title: Diagnosis of Peripheral Pulmonary Lesions: Benefit of Endoscopic Sample Under Fluoroscopic Controle After Non Contributive Endoscopic Samples Guided by Radial EBUS-miniprobe.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Peripheral Pulmonary Lesions
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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,...).

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)

Primary outcomes:
measure: Percentage Definitive anatomopathological diagnosis
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHu Saint Pierre
Study officials:
affiliation: CHU St Pierre
name: Marie Bruyneel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: