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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02538380
• Other study ID #: NL50139.018.14
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: August 31, 2015
• Start date: March 2015

Study information

• Verified date: June 2015
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Laurence MM Crombag, MD
• Phone: +31205664356
• Email: l.m.crombag[@]amc.nl
• Is FDA regulated: No
• Health authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Lung Neoplasms
• Suspected Left Adrenal Gland Metastasis in Lung Cancer

Intervention

Procedure:
• EUS-B-FNA followed by EUS-FNA for LAG analysis

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam
Netherlands	University Hospital Nijmegen	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 3 weeks after inclusion	Yes