Multicentric Prospective Validation of the Zurich Pituitary Score

NCT04076046 | Completed

• 1 other identifier: ZPS prospective validation
• Study Type: observational
• Target: 408
• Locations: 6 countries
• Sites: 10

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.

Conditions

Pituitary Adenoma

Keywords

pituitary adenoma endoscopic surgery zurich pituitary score

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive serie of patients undergoing endoscopic transsphenoidal pituitary adenoma surgery

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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (10)

Donald and Barbara Zucker School of Medicine at Hofstra/Northwell

New York, New York, 11030, United States

Location

Department of Neurosurgery, Kepler Universitäts Klinikum

Linz, Austria

Location

Toronto Western Hospital, University of Toronto

Toronto, Canada

Location

Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital

Prague, Czechia

Location

IRCCS Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, Italy

Location

Universita' degli Studi Federico II

Napoli, Italy

Location

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

Varese, Italy

Location

CHUV

Lausanne, Switzerland

Location

Department of Neurosurgery

Zurich, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31392567 BACKGROUND

• 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.

  PMID: 30267209 BACKGROUND

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Carlo Serra, MD

  Klinik für Neurochirurgie, UniversitätsSpital Zürich, Switzerland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 3, 2019
• Study Start: November 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2); AU (1); CA (1); IT (4); US (1); CZ (1)