Multicentric Prospective Validation of the Zurich Pituitary Score

Pituitary Adenoma Clinical Trial

Official title:

Multicentric Prospective Validation of the Zurich Pituitary Score

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04076046
• Other study ID #: ZPS prospective validation
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: December 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Locations

Country	Name	City	State
Austria	Department of Neurosurgery, Kepler Universitäts Klinikum	Linz
Canada	Toronto Western Hospital, University of Toronto	Toronto
Czechia	Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital	Praha
Italy	IRCCS Istituto delle Scienze Neurologiche di Bologna	Bologna
Italy	Azienda Ospedaliera Universitaria Careggi	Firenze
Italy	Universita' degli Studi Federico II	Napoli
Italy	Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria	Varese
Switzerland	CHUV	Lausanne
Switzerland	Department of Neurosurgery	Zürich
United States	Donald and Barbara Zucker School of Medicine at Hofstra/Northwell	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Czechia,  Italy,  Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gross Total Resection	Gross Total Resection on magnetic resonance imaging	2 to 4 months postoperatively
Primary	Extent of Resection	Percentage of removed adenoma volume on magnetic resonance imaging	2 to 4 months postoperatively
Primary	Residual Adenoma Volume	Percentage of original adenoma volume still visible at the postoperative magnetic resonance imaging	2 to 4 months postoperatively
Primary	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