Suspected Left Adrenal Gland Metastasis in Lung Cancer Clinical Trial
Official title:
EUS-B-FNA vs EUS-FNA for Left Adrenal Gland Analysis in Lung Cancer
The purpose of this study is to compare EUS-B-FNA (using the EBUS scope)with EUS-FNA for left adrenal gland analysis in lung cancer patients.
Rationale:
The adrenal glands are a predilection site for distant metastases (M1b) in patients with
lung cancer.
However, even in a patient with a confirmed lung cancer an enlarged adrenal lesion is still
more likely to be benign than to be malignant(4). Therefore tissue sampling of the left
adrenal gland (LAG) is obligatory to either confirm or rule out metastases. Sampling is
regularly performed by a transgastric endoscopic approach using a conventional GI-EUS scope.
The aim of this study is investigate the success rate of endoscopic ultrasound guided
fine-needle aspiration using the EBUS scope (EUS-BFNA) for left adrenal gland analysis in
patients with lung cancer and an on imaging suspected left adrenal gland.
Hypothesis:
EUS-B guided transgastric FNA of suspected left adrenal glands (LAG) reduces the need for
conventional EUS- FNA by half.
Study design:
A prospective cohort design Setting: international, multicenter
Study population:
Patients with (suspected) lung cancer, an indication for mediastinal nodal staging and a for
malignancy suspected LAG on imaging.
Intervention:
All patients will undergo a mediastinal nodal staging procedure with the EBUS scope (EBUS +
EUSB) (routine clinical care) followed by an evaluation of the LAG including LAG sampling
(experimental). Subsequently, all patients undergo a conventional EUS procedure with
sampling of the LAG (current standard of care)
Main study endpoint:
The proportion of patients with a successful EUS-B-FNA procedure for LAG analysis.
Successful is defined as: LAG is visible, sampling is possible and adequate material for
cytopathological evaluation is obtained. Nature and extent of the burden and risks
associated with participation, benefit and group relatedness: Distant metastases of lung
cancer like LAG metastases have significant impact on both the prognosis and treatment. In
the majority of patients with an indication for LAG sampling by endosonography, there is
also an indication for mediastinal nodal tissue sampling. In case both the mediastinal lymph
nodes and the LAG can be evaluated with the same scope, patients can be evaluated for nodal
and distant metastasis with just a single instead of two separate scopes. This will be
beneficial for patients (reduced investigation time) and is additionally cost -effective. So
far EUS-B of LAG has been shown to be safe and feasible.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic