Multicentric Prospective Validation of the Zurich Pituitary Score

NCT ID: NCT04076046

Last Updated: 2021-12-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 408 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-12-01

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.

Conditions

Pituitary Adenoma

Keywords

pituitary adenoma endoscopic surgery zurich pituitary score

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Carlo Serra

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlo Serra, MD

Role: STUDY_DIRECTOR

Klinik für Neurochirurgie, UniversitätsSpital Zürich, Switzerland

Locations

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

Napoli, , Italy

Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria

Varese, , Italy

CHUV

Lausanne, , Switzerland

Department of Neurosurgery

Zurich, , Switzerland

Countries

United States; Austria; Canada; Czechia; Italy; Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 31392567 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30267209 (View on PubMed)

Other Identifiers

ZPS prospective validation

Identifier Type: -

Identifier Source: org_study_id