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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Completed
CT.gov ID
NCT06053437
Collaborator
(none)
211
1
7
30.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    211 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Prognostic Indicators in Pituitary Adenoma Surgery: a Comprehensive Analysis of Surgical Outcomes and Complications.
    Actual Study Start Date :
    Feb 1, 2023
    Actual Primary Completion Date :
    Jul 15, 2023
    Actual Study Completion Date :
    Sep 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Hyp'Op Cohort

    The 'HYP'OP' cohort comprises patients who underwent endoscopic endonasal surgery (EES) for pituitary adenoma during a 10-year period spanning from January 2012 to June 2022 at the Nancy University Hospital. Post-operative hospitalization in our endocrinology department is part of the standard care protocol, which also includes a systematic reevaluation 4 -6 months following the surgical intervention.

    Outcome Measures

    Primary Outcome Measures

    1. Risk factors associated with complications [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 Outcome Measures

    1. Factors predictive of the 'success' of surgery [Within 6 months after surgery]

      Patients were stratified into groups based on surgical indications. The first group consisted of non-secreting, non-compressive adenomas without preoperative insufficiency or hyperprolactinemia, with success defined as absence of new insufficiency and no MRI-detected residual tissue. The second group was similar to the first but included disconnection hyperprolactinemia, and success was defined by the absence of new insufficiency and hyperprolactinemia regression. The third group involved non-secreting adenomas with at least one preoperative axis deficiency, irrespective of hyperprolactinemia, with success defined as restoration of at least one deficient axis without new insufficiency. The fourth group included secreting adenomas, with success defined as hypersecretion regression. The fifth group involved adenomas operated on for their compressive effect on the optic pathways, with or without hyperprolactinemia, and success was defined as no compression observed on follow-up MRI.

    2. Is immediate postoperative hypoprolactinemia predictive of the onset of a new, clinically significant hormonal insufficiency? [Within 6 months after surgery]

      patients were stratified into four groups based on immediate postoperative prolactin levels: Group 1 consisted of severe hypoprolactinemia; Group 2 included moderate hypoprolactinemia; Group 3 involved normal prolactin levels, defined by prolactin levels between 5 and 20 ng/ml; and Group 4 comprised hyperprolactinemia, defined by prolactin levels > 20 ng/ml. It should be noted that these instances of hyperprolactinemia are theoretically all disconnection hyperprolactinemias, as patients with lactotroph adenomas were excluded from this analysis. Patients under treatment for hyperprolactinemia were also excluded.

    Other Outcome Measures

    1. Is hypoprolactinemia at the 4-month follow-up is correlated with the number of affected pituitary axes? [Within 6 months after surgery]

      Patients were stratified into four groups using the same criteria as outlined in Outcome 3.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma.
    Exclusion Criteria:
    • No 4 month evaluation.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier RĂ©gional Universitaire de Nancy Nancy France 54035

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DEMARQUET Lea, Principal Investigator, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT06053437
    Other Study ID Numbers:
    • 2022PI198
    First Posted:
    Sep 25, 2023
    Last Update Posted:
    Sep 26, 2023
    Last Verified:
    Sep 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DEMARQUET Lea, Principal Investigator, Central Hospital, Nancy, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 26, 2023