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conclusive diagnosis of unilateral PA by the "four corners" criteria:

1. Biochemical evidence of PA
2. Lateralization of aldosterone secretion at adrenal venous sampling.
3. Correction of biochemical values and fall of blood pressure after adrenalectomy.
4. Immunohistochemical demonstration of CYP11B2 positive nodule(s)

Presumed diagnosis of bilateral PA, defined as above but without evidence of lateralized aldosterone excess.

Primary (essential) Hypertension (PH): conclusively ascertained high blood pressure and exclusion of secondary hypertension

comprising patients submitted to surgery but free of hypertension

Skin biopsies were obtained in all recruited patients.

Skin Biopsy

Video-laparoscopic adrenalectomy in those with unilateral PA. (PA group 1)

Video-laparoscopic adrenalectomy

Gian Paolo Rossi, Prof.

WHYSKI is a prospective within-patient observational clinical study designed to test the hypothesis that alterations of Na+, K+, water, and the lympho-angiogenetic transcription factor Tonicity Enhancing Binding Protein (TonEBP) mRNA take place in the interstitium of the skin compartment of patients with arterial hypertension due to primary aldosteronism in whom hypertension can be surgically cured.

Background. Given the key role of Na+ in the pathophysiology of HT, this study will test the hypothesis that in PA, which is the paradigm of salt-dependent hypertension, the skin, Na+, K+ and water content is altered and these alterations are corrected by surgical cure of PA with video-laparoscopic adrenalectomy. The investigators will use skin biopsies to directly examine the content of Na+, K+, water, and the lympho-angiogenetic transcription factor Tonicity Enhancing Binding Protein (TonEBP) mRNA in the skin, an important reservoir of body Na+, in primary aldosteronism (PA), the prototype of salt-dependent hypertension.

Methods. The investigators will measure Na+, K+, and water content (by chemical-physical methods) and TonEBP mRNA copy number (by droplet digital PCR) in skin biopsies from a sex-mixed cohort of consecutive consenting patients with unilateral PA treated with a mineralocorticoid receptor antagonist (MRA), before surgery, at doses that correct hypokalemia and HT in order to refer them for surgery with normokalemia and controlled high blood pressure, as per protocol at our institution. The participants will be reassessed in an identical way again after surgical cure.

The investigators expect the dry weight (DW) of the skin specimen obtained at surgery to be significantly higher than at follow-up and to correlate positively with skin Na+, K+, and water content. Hence, if these predictions will be verified, the skin cations and water content will need to be DW-adjusted in order to provide meaningful comparisons across specimen obtained at different time points. The investigators expect the TonEBP mRNA copy number to be markedly overexpressed compared to healthy subjects.

The WHYSKI study will provide solid knowledge of the skin Na+, K+ and water content in patients with arterial salt-dependent hypertension due to PA, PH, and on the effect of cure of the hyperaldosteronism on these variables. The investigators also expect to gather novel knowledge on the molecular and cellular mechanisms involved in the regulation of the content on Na+, K+ and water in a compartment as the skin interstitium that has been largely neglected thus far.

Water and Electrolytes Content in HYpertension (WHYSKI) in the SKIn

The Water and Electrolytes Content in Salt-dependent Human HYpertension (WHYSKI) in the SKIn Before and After Surgical Cure of Primary Aldosteronism

IPD available on reasonable request but if consistent with the ongoing privacy legislation.

With validated chemical physical methods, we will measure the Na+, K+ and water content in the skin of patients with primary aldosteronism (PA, PA Group), primary (essential) hypertension HT patients (PH Group) and in normotensive patients (Control Group). The skin biopsy will be performed during adrenalectomy in consecutive patients with confirmed unilateral PA (PA Group) and in parallel in the same anatomical region in the PH group and in the Control Group, during surgery for benign diseases.

To verify if the cure of PA improves Na+, K+ and water skin clearance in the PA Group the skin biopsy obtained during adrenalectomy will be within-patient compared to that obtained one month after adrenalectomy (PA Group 1). In PA patients found not to have unilateral PA (PA Group 2), the biopsy will be obtained after one month of target medical treatment with canrenone, a mineralocorticoid receptor antagonist.

While the measurement of skin Na+, K+ and water is the main study outcome, an additional important goal will be to determine the molecular mechanisms driven by "skin sodium storage" that underlie the crosstalk between skin cells, macrophages and lymphatic vessels in the interstitium of the patient with PA (PA group 1) and essential hypertensive patients (EH Group) compared with the normotensive patient (Control Group). To this end we will explore the mRNA content of Tonicity-Enhancing Binding Protein TonEBP (also known as NFAT5), a transcription factor known to activate neo-lymphoangiogenesis, using molecular biology techniques.

University Hospital Padova

Full Professor of Internal Medicine, MD, FAHA, FACC

Pheochromocytoma

Neoplasm Metastasis

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Oculocerebral Syndrome With Hypopigmentation

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

In 13 patients, 14 posterior retroperitoneal adrenalectomy procedures were successfully completed and form the non-conversion group

Conversion to lateral transperitoneal adrenalectomy was necessary in 1 patient after starting posterior retroperitoneal adrenalectomy.

Minimally invasive adrenalectomy procedure

Posterior retroperitoneal adrenalectomy (PRA)

During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs.

Lateral transperitoneal adrenalectomy (LTA)

Christian A Nebiker, PD Dr. med.

With our retrospective study the investigators show the limitations of the posterior retroperitoneal adrenalectomy by analyzing anatomical parameters.

The investigators compared the data from one patient who underwent a conversion with 13 patients without a conversion. Furthermore, they explored the influence of these parameters on the operation time and excluded the patient who had a conversion from this analysis.

The investigators hypothesize that by determining anatomical characteristics on cross-sectional imaging (CT or MRI), they can show the limitations of the posterior retroperitoneal adrenalectomy to prevent patients from being converted to lateral transperitoneal adrenalectomy.

Minimally invasive adrenalectomy has become the gold standard for the surgical treatment of small, benign adrenal lesions. In addition to the common laparoscopic lateral transperitoneal adrenalectomy, the posterior retroperitoneal adrenalectomy is becoming increasingly important.

To date, there is no consensus regarding the preferred approach in the resection of benign adrenal tumors. A comprehensive adrenal tumor program should be able to offer both options, however, patient selection criteria for a given approach have not yet been defined. The choice between lateral transperitoneal adrenalectomy and posterior retroperitoneal adrenalectomy is relevant for patients with unilateral tumors \< 6-7 cm and without previous abdominal surgery.

The aim of this study was to determine the limits of posterior retroperitoneal adrenalectomy using anatomical parameters to enable the preferred access to be chosen preoperatively to prevent conversion. In addition, the investigators describe the relationship between these parameters and the operation time to find a measure of the degree of technical difficulty.

Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions

Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions on Cross-sectional Imaging (CT or MRI)

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal distance between the dorsal border of the adrenal gland and the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Defined as the largest distance between the kidney parenchyma and the posterior abdominal wall at the level where the renal vein joins the vena cava inferior.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Distance from skin to renal parenchyma through the 12th rib tip. The larger the distance, the larger the index. The scale ranges are open.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the upper pole of the kidney and the inferior border of the adrenal gland, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the superior border of the adrenal gland to the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Longitudinal distance between the 12th rib and the iliac crest, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer above the iliac crest, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Thickness of the subcutaneous layer above the 12th rib tip, measured on the straight line to the center of gravity, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Sagittal thickness of the subcutaneous layer between the center of gravity and the lateral border of the body, measured at the level of the 12th rib tip, mm.

Measurement of preoperative anatomical conditions on cross- sectional imaging (CT or MRI). Tumor size, cm.

Duration of adrenalectomy. Data were extracted and analyzed from the hospital information system.

Value derived from the mass (weight) and height of a person. Data were extracted and analyzed from the hospital information system.

Side of the removed adrenal gland (left, right, bilateral). Data were extracted and analyzed from the hospital information system.

Previous abdominal operations with opening of the abdominal cavity which give an indication of adhesions.Data were extracted and analyzed from the hospital information system.

Age at adrenalectomy. Data were extracted and analyzed from the hospital information system.

Histological evaluation. Data were extracted and analyzed from the hospital information system.

Kantonsspital Aarau

University of Basel

BMed

Carcinoma

Cushing Syndrome

Adrenocortical Carcinoma

Adenocarcinoma

Cushing's Syndrome

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
Water and Electrolytes Content in HYpertension (WHYSKI) in the SKIn	NCT06090617	Hyperaldosteron... Hypertension Aldosterone-pro... Aldosteronism Aldosterone Dis... Essential Hyper... Bilateral Adren... Conn Adenoma	Skin Biopsy Video-laparosco...	18 Years - 75 Years	University Hospital Padova
Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions	NCT04071561	Adrenal Tumor Adrenal Mass Pheochromocytom... Conn Adenoma Adrenal Metasta... Adrenal Hyperpl...	Posterior retro... Lateral transpe...	18 Years -	University of Basel
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
Prevention of Conversion in Posterior Retroperitoneal Adrenalectomy by Measuring Preoperative Anatomical Conditions	NCT04071561	Adrenal Tumor Adrenal Mass Pheochromocytom... Conn Adenoma Adrenal Metasta... Adrenal Hyperpl...	Posterior retro... Lateral transpe...	18 Years -	University of Basel

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