EUS-B-FNA vs EUS-FNA for Left Adrenal Gland Analysis in Lung Cancer Patients

Not Applicable

• Conditions: Suspected Left Adrenal Gland Metastasis in Lung Cancer
• Interventions: Procedure: EUS-B-FNA followed by EUS-FNA for LAG analysis

• Registration Number: NCT02538380
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-03
• Status Verified: 2015-06
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-08-31
• Last Update Submitted: 2015-08-31
• Study First Posted: 2015-09-02
• Last Update Posted: 2015-09-02
• Primary Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• (Suspected) Lung Cancer
• For malignancy suspected LAG on imaging (enlarged based on CT and/or FDG avid based on FDG-PET);
• Indication for endosonographic mediastinal staging by EBUS;
• Indication for LAG sampling;

Exclusion Criteria

• Contraindication for EUS;
• Pregnancy;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EUS-B-FNA for LAG analysis	EUS-B-FNA followed by EUS-FNA for LAG analysis	All patients will undergo a mediastinal nodal staging procedure with the EBUS scope (EBUS + EUS-B) (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)

Primary Outcome Measures

Name	Time	Method
The proportion of patients with a successful EUS-B-FNA procedure for LAG analysis.	within 3 weeks after inclusion	Successful is defined as: LAG is visible, sampling is possible and adequate material for cytopathological evaluation is obtained.

Trial Locations

Locations (2)

University Hospital Nijmegen; 🇳🇱 Nijmegen, Netherlands

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands