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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)

EUS-B-FNA followed by EUS-FNA for LAG analysis

Laurence MM Crombag, MD

Jouke T Annema, MD PhD

Laurence Crombag, MD

Olga Schuurbiers, MD PhD

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.

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

Successful is defined as: LAG is visible, sampling is possible and adequate material for cytopathological evaluation is obtained.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Prof Dr

Gland and Hormone Related Diseases

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MUDr. Igor Hartmann Ph.D.

Natalia Wiesner

Igor Hartmqnn, MD, PhD

Natalia Wiesner, MD

Igor Hartmann, MD, PhD

The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are:

1. to find the superiority of one the the surgical method mentioned above
2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy

Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study

Initial examination by a urologist and indication for the surgery.

Sampling of biological material: Hemoglobin g/l

Measuring the blood loss in milliliters (ml).

Record the need for conversion to open surgery.

The consumption of special surgical instruments.

Perioperatively, the length of stay in the ICU in days.

Perioperatively, total hospitalization time in days

Perioperatively, blood loss from the drain in mililiters (ml).

Perioperatively, time to remove the abdominal drain in days.

Perioperatively, need for blood substitutes.

Perioperatively, number of forced surgical revisions.

Perioperatively, consumption of analgesics during the hospitalization.

First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l

First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification

First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.

Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.

Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EUS-B-FNA vs EUS-FNA for Left Adrenal Gland Analysis in Lung Cancer Patients	NCT02538380	Suspected Left ...	EUS-B-FNA follo...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy	NCT06050057	Adrenal Tumor Adrenal Disease Adrenal Mass Adrenalectomy; ... Adrenal Hyperpl... Adrenal Gland M... Adrenal Cortex ... Pheochromocytom... Cushing Syndrom... Conn Adenoma Adrenocortical ... Adrenocortical ... Adrenocortical ...		18 Years -	University Hospital Olomouc
EUS-B-FNA vs EUS-FNA for Left Adrenal Gland Analysis in Lung Cancer Patients	NCT02538380	Suspected Left ...	EUS-B-FNA follo...	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for adrenal gland metastasis