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Clinical Trials/NCT06053437
NCT06053437
Completed
Not Applicable

Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.

Central Hospital, Nancy, France1 site in 1 country211 target enrollmentFebruary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pituitary Adenoma
Sponsor
Central Hospital, Nancy, France
Enrollment
211
Locations
1
Primary Endpoint
Risk factors associated with complications
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Predicting the outcome of pituitary surgery, particularly the risk of complications, is a critical determinant in selecting the appropriate treatment modality for patients. To date, only a limited number of risk factors have been identified for complications following pituitary surgery, including tumor size, younger age, and previous surgical intervention. Furthermore, existing studies have demonstrated that prolactin levels can serve as a surrogate marker for assessing pituitary function, specifically revealing associations between elevated prolactin levels and anterior pituitary insufficiencies.

In a retrospective study on the "HYP'OP" cohort, the aim of the study is to identify predictive factors for both surgical outcomes and complications.

Registry
clinicaltrials.gov
Start Date
February 1, 2023
End Date
September 1, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

DEMARQUET Lea

Principal Investigator

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • Transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma.

Exclusion Criteria

  • No 4 month evaluation.

Outcomes

Primary Outcomes

Risk factors associated with complications

Time Frame: Within 6 months after surgery

Risk factors associated with complications arising from surgery, specifically targeting the incidence of de-novo, clinically significant pituitary insufficiencies

Secondary Outcomes

  • Factors predictive of the 'success' of surgery(Within 6 months after surgery)
  • Is immediate postoperative hypoprolactinemia predictive of the onset of a new, clinically significant hormonal insufficiency?(Within 6 months after surgery)

Study Sites (1)

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