projects I

Sven Berkmann (1), Javier Fandino (1), Beat Müller (2), Philipp Schütz (2)

Surgical and biochemical outcomes of patients treated for pituitary pathologies at the Kantonsspital Aarau (SwissPit Outcome Study)

(1) Department of Neurosurgery, Kantonsspital Aarau, Aarau/Switzerland

(2) Medical University Clinic, Kantonsspital Aarau, Aarau/Switzerland

  • retrospective
  • monocentric
  • started 01.02.2016
  • recruiting

  • INTRODUCTION. Sellar tumors are common intracranial neoplasms. Nevertheless, most of these tumors remain undetected, unless they cause endocrinological syndroms, symptoms of local mass effect, or are found incidentally on neuroimaging, why they are defined as orphan diseases. The centerpiece of one of the pituitary networks in Switzerland is the Kantonsspital Aarau. The department of neurosurgery treats referrals from several cantons (AG, SO, ZG, SZ, UR, NW, OW) in close cooperation with the endocrinological clinic of the medical university department. A registry has been founded with the goals of pooling patients for clinical studies and including other pituitary care centers.

    AIM. The objective of this study is to investigate surgical and biochemical outcomes in patients treated for pituitary pathologies. To gather patient data for the analysis we will use baseline and outcome data entered in the Swiss pituitary registry. Our primary endpoint is adverse surgical and biochemical outcome defined as: need for surgical operation due to tumor mass effect or local complication; tumor progression as evidenced in MRI; worsening pituitary function with need of medical treatment; death of any cause. We will look at time to event and use the first adverse outcome for the primary analysis.

    METHODS. The acquired observational data resulting from procedures of routine clinical care will be collected in an electronic data capture system named secuTrial®. Currently about 180 patients eligible for retrospective inclusion are routinely undergoing controls and will be evaluated and consented. About 50 newly diagnosed patients per year will be eligible for prospective inclusion. An interim analysis will be performed after inclusion of the following numbers of patients with specific diagnoses: nonfunctioning adenoma, n=100; acromegaly, n=30; prolactinoma, n=40; Cushing’s disease, n=20; cystic lesions, n=30. A request for ethical approval of collecting the necessary data in the Swiss pituitary registry has been given. Specific requests will be submitted for the publications addressing the study outcomes listed above.

    last update 08.12.2017