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

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.

Study Overview

• Status: Unknown
• Conditions: Suspected Left Adrenal Gland Metastasis in Lung Cancer
• Intervention / Treatment: Procedure: EUS-B-FNA followed by EUS-FNA for LAG analysis

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurence MM Crombag, MD; Phone Number: +31205664356; Email: l.m.crombag@amc.nl
• Study Contact Backup: Name: Jouke T Annema, MD PhD; Phone Number: +31205663173; Email: j.t.annema@amc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Recruiting
    • Academic Medical Center
    • Contact: Laurence Crombag, MD; Phone Number: +31205664356; Email: l.m.crombag@amc.nl
  • Nijmegen, Netherlands
    • Recruiting
    • University Hospital Nijmegen
    • Contact: Olga Schuurbiers, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-B-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)	Procedure: EUS-B-FNA followed by EUS-FNA for LAG analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Jouke T Annema, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Estimate): September 2, 2015
• Last Update Submitted That Met QC Criteria: August 31, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Lung cancer; Adrenal gland metastasis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: NL50139.018.14