Multicentric Prospective Validation of the Zurich Pituitary Score

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicentric Prospective Validation of the Zurich Pituitary Score

Conditions
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Pituitary Adenoma

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross Total Resection | Gross Total Resection on magnetic resonance imaging | 2 to 4 months postoperatively | 
| Extent of Resection | Percentage of removed adenoma volume on magnetic resonance imaging | 2 to 4 months postoperatively | 
| Residual Adenoma Volume | Percentage of original adenoma volume still visible at the postoperative magnetic resonance imaging | 2 to 4 months postoperatively | 
| Zurich Pituitary Score | Four-tier score as follows: Grade Criteria I R < 0.75 II 0.75 < R < 1.25 III 1.25 < R IV Encasement of the intracavernous ICA R = ratio of maximum horizontal tumor diameter divided by the minimum intercarotid distance at the intracavernous horizontal C4 segment of the ICA. | On preoperative MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pituitary adenoma endoscopic surgery zurich pituitary score