Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03422744 |
| Other study ID # |
B076201733056 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 3, 2017 |
| Est. completion date |
September 30, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Centre Hospitalier Universitaire Saint Pierre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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,…).
