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

NCT06053437 | Completed

• 1 other identifier: 2022PI198
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma; Surgery-Complications

Keywords

transsphenoidal surgery; pituitary adenoma; post-operative complications

Outcome Measures

Primary Outcomes (1)

• Risk factors associated with complications

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

  Within 6 months after surgery

Secondary Outcomes (2)

• 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

Other Outcomes (1)

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

  Within 6 months after surgery

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

All patients having undergone transsphenoidal pituitary surgery at Nancy University Hospital (France) between 2012 and 2022 for a pituitary adenoma are to be included.

You may qualify if:

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

You may not qualify if:

• No 4 month evaluation.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54035, France

Location

Related Publications (1)

• Riley G, Scheyer N, Klein M, Merlot I, Guerci B, Jeanbert E, Demarquet L. Prognostic indicators in pituitary adenoma surgery: a comprehensive analysis of surgical outcomes and complications. Front Endocrinol (Lausanne). 2024 Jan 11;14:1327404. doi: 10.3389/fendo.2023.1327404. eCollection 2023.

  PMID: 38274233 DERIVED

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: September 25, 2023
• Study Start: February 1, 2023
• Primary Completion: July 15, 2023
• Study Completion: September 1, 2023
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)