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OpenTrials
Completed

NCT Number: NCT06053437

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No 4 month evaluation.

Treatment and study plan

Primary outcomes

  1. 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

  1. Factors predictive of the 'success' of surgery

    Time frame: 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?

    Time frame: 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 outcomes

  1. Is hypoprolactinemia at the 4-month follow-up is correlated with the number of affected pituitary axes?

    Time frame: Within 6 months after surgery

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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: Hyp'Op

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2023
Registry last updated
Sep 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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