Multicentric Prospective Validation of the Zurich Pituitary Score

December 2, 2021 updated by: Carlo Serra, University of Zurich

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
        • Department of Neurosurgery, Kepler Universitäts Klinikum
  • Canada
      • Toronto, Canada
        • Toronto Western Hospital, University of Toronto
  • Czechia
      • Praha, Czechia
        • Department of Neurosurgery and Neurooncology, First Faculty of Medicine, Charles University and Military University Hospital
  • Italy
      • Bologna, Italy
        • IRCCS Istituto delle Scienze Neurologiche di Bologna
      • Firenze, Italy
        • Azienda Ospedaliera Universitaria Careggi
      • Napoli, Italy
        • Universita' degli Studi Federico II
      • Varese, Italy
        • Reparto di Neurochirurgia, Ospedale di Circolo e Fondazione Macchi, Universita' dell'Insubria
  • Switzerland
      • Lausanne, Switzerland
        • CHUV
      • Zürich, Switzerland
        • Department of Neurosurgery
  • United States
    • New York
      • New York, New York, United States, 11030
        • Donald and Barbara Zucker School of Medicine at Hofstra/Northwell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive serie of patients undergoing endoscopic transsphenoidal pituitary adenoma surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gross Total Resection
Time Frame: 2 to 4 months postoperatively
Gross Total Resection on magnetic resonance imaging
2 to 4 months postoperatively
Extent of Resection
Time Frame: 2 to 4 months postoperatively
Percentage of removed adenoma volume on magnetic resonance imaging
2 to 4 months postoperatively
Residual Adenoma Volume
Time Frame: 2 to 4 months postoperatively
Percentage of original adenoma volume still visible at the postoperative magnetic resonance imaging
2 to 4 months postoperatively
Zurich Pituitary Score
Time Frame: On preoperative MRI

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Study Director: Carlo Serra, MD, Klinik für Neurochirurgie, UniversitätsSpital Zürich, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

August 29, 2019

First Submitted That Met QC Criteria

August 29, 2019

First Posted (Actual)

September 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 2, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZPS prospective validation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pituitary Adenoma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe