Multicentric Prospective Validation of the Zurich Pituitary Score
Completed
Conditions studied: Pituitary Adenoma
In brief
Predictive analytics for GTR, EOR and RV are useful in surgical decision-making, particularly whenever there is no unequivocal indication for surgery. Several factors have been shown to have a role in predicting GTR. Among these, the Knosp classification has proven over the years to be a good predictor of GTR. The score is based on the lateral extension of the adenoma in relation the the intracranial bedding of the internal carotid artery. However, recent literature has demonstrated that the Knosp classification suffers from relatively poor interrater agreement. Moreover the classification was conceived in an era when endoscopic techniques were not available: nowadays endoscopic technique allows visualization and possibly also reaching portions of adenoma which at the time when the Knosp classification was introduced were simply not possible. Lastly, the efficacy of the Knosp's score in predicting also EOR and RV has never been tested. Recently a new score - the Zurich Pituitary Score (ZPS) has been proposed at the University Hospital of Zürich (USZ). The score has proved in the examined series to be more powerful than the Knosp classification in predicting GTR, EOR and RV. A good interrater agreement was also demonstrated. The score however, has been validated only in a monocentric setting with a limited number of patients. The aim of this study is to assess the (1) predictive ability of the ZPS for GTR, EOR, and RV, and (2) the inter-rater agreement of the ZPS in an external validation study.
Key facts
- Study ID
- NCT04076046
- Run by
- University of Zurich
- People needed
- 408
- Starts
- 2019-11-01
- Expected to finish
- 2021-12-01
- Last updated by the study team
- 2021-12-17
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients harboring suspected pituitary adenoma.
- Patients undergoing endoscopic transsphenoidal surgery
- Preoperative MRI including at least one volumetric sequence (i.e. MPRAGE or SPGR) with gadolinium with possibility for coronal reconstructions
- Postoperative MRI (2-4 months postoperative) including at least one volumetric sequence (i.e. MPRAGE or SPGR) with Gadolinium with possibility for coronal reconstructions
You may not qualify if…
- Patients undergoing combined or transcranial operations
- Patients for whom a biopsy only is planned
- Patients by whom histology does not confirm the diagnosis of pituitary adenoma
Where it is running
- Donald and Barbara Zucker School of Medicine at Hofstra/Northwell — New York, New York, United States
- Department of Neurosurgery, Kepler Universitäts Klinikum — Linz, Austria
- Toronto Western Hospital, University of Toronto — Toronto, Canada
- Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital — Prague, Czechia
- IRCCS Istituto delle Scienze Neurologiche di Bologna — Bologna, Italy
- Azienda Ospedaliera Universitaria Careggi — Florence, Italy
- Universita' degli Studi Federico II — Naples, Italy
- Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria — Varese, Italy
- CHUV — Lausanne, Switzerland
- Department of Neurosurgery — Zurich, Switzerland
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.