Clinical trial NCT04076046: Multicentric Prospective Validation of the Zurich Pituitary Score
Official title: Multicentric Prospective Validation of the Zurich Pituitary Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Keywords: pituitary adenoma endoscopic surgery zurich pituitary score
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 408
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive serie of patients undergoing endoscopic transsphenoidal pituitary adenoma surgery

Brief summary: 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.

Detailed description: In transsphenoidal surgery (TSS) for pituitary adenoma (PA), gross total resection (GTR) is often the target since it has been shown to relevantly influence long term patient outcome. This applies both to functioning adenomas (FA) as well as to non-functioning adenomas (NFPA). Mounting evidence shows that in cases where GTR is not achievable, maximizing extent of resection (EOR) is still highly desirable, particularly in case of FA, with the aim of obtaining the smallest possible residual volume (RV).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gross Total Resection
timeFrame: 2 to 4 months postoperatively
measure: Extent of Resection
timeFrame: 2 to 4 months postoperatively
measure: Residual Adenoma Volume
timeFrame: 2 to 4 months postoperatively
measure: Zurich Pituitary Score
timeFrame: On preoperative MRI
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Donald and Barbara Zucker School of Medicine at Hofstra/Northwell
state: New York
city: Linz
country: Austria
facility: Department of Neurosurgery, Kepler Universitäts Klinikum
city: Toronto
country: Canada
facility: Toronto Western Hospital, University of Toronto
city: Praha
country: Czechia
facility: Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital
city: Bologna
country: Italy
facility: IRCCS Istituto delle Scienze Neurologiche di Bologna
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi
city: Napoli
country: Italy
facility: Universita' degli Studi Federico II
city: Varese
country: Italy
facility: Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria
city: Lausanne
country: Switzerland
facility: CHUV
city: Zürich
country: Switzerland
facility: Department of Neurosurgery
Study officials:
affiliation: Klinik für Neurochirurgie, UniversitätsSpital Zürich, Switzerland
name: Carlo Serra, MD
role: STUDY_DIRECTOR
References:
citation: Staartjes VE, Serra C, Maldaner N, Muscas G, Tschopp O, Soyka MB, Holzmann D, Regli L. The Zurich Pituitary Score predicts utility of intraoperative high-field magnetic resonance imaging in transsphenoidal pituitary adenoma surgery. Acta Neurochir (Wien). 2019 Oct;161(10):2107-2115. doi: 10.1007/s00701-019-04018-9. Epub 2019 Aug 7.
citation: Serra C, Staartjes VE, Maldaner N, Muscas G, Akeret K, Holzmann D, Soyka MB, Schmid C, Regli L. Predicting extent of resection in transsphenoidal surgery for pituitary adenoma. Acta Neurochir (Wien). 2018 Nov;160(11):2255-2262. doi: 10.1007/s00701-018-3690-x. Epub 2018 Sep 29.