Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma

A Hypothalamic Injury-Stratified Nursing Care Pathway for Pediatric Craniopharyngioma Survivors: Advancing Nursing Leadership in Complex Chronic Disease Management

The goal of this multicenter retrospective cohort study is to determine whether MRI-graded hypothalamic injury severity predicts growth-hormone deficiency (GHD) and neuropsychological morbidity in 500 children and adolescents (≤ 18 y) who underwent craniopharyngioma resection at six Chinese pediatric centers between 2013 and 2023 and were followed ≥ 2 years. The main questions it aims to answer are:

1. Does increasing hypothalamic injury grade (Grade 0 = uninvolved, Grade 1 = mild compression, Grade 2 = significant invasion) independently correlate with higher incidence of GHD, lower IGF-1 levels, greater height SDS decline, and increased need for recombinant human GH therapy?
2. Is higher injury grade associated with worse neuropsychological outcomes-lower IQ, impaired executive function, emotional disorders, and obesity-after adjustment for age, tumor size, and extent of resection?

Researchers compared the three injury-grade groups to quantify endocrine and neuro-behavioral outcomes and to catalog differentiated nursing needs (growth monitoring frequency, dietary-behavioral plans, psychological support intensity, comorbidity surveillance). Participants underwent pre- and post-operative MRI grading by blinded neuroradiologists, standardized endocrine stimulation tests, annual neuropsychological testing (WISC-IV, BRIEF, CBCL), and detailed nursing-documentation review; all data were analyzed with Spearman correlation, ANOVA, and multivariable logistic regression.

Study Overview

• Status: Completed
• Conditions: Craniopharyngioma; Growth Hormone Deficiency (GHD)

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital of Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

**Study Population Description** Children and adolescents ≤ 18 years of age who underwent primary surgical resection for craniopharyngioma at one of six tertiary pediatric centers in China between January 2013 and December 2023, had complete pre- and post-operative brain MRI, endocrine, and neuropsychological data, and were followed for ≥ 2 years without tumor re-operation.

Description

Inclusion Criteria:

• Age ≤18 years at the time of craniopharyngioma resection;
• Pathologically confirmed craniopharyngioma;
• Postoperative follow-up duration ≥2 years;
• Complete preoperative and postoperative MRI data, endocrine test results, neuropsychological assessment records, and nursing documentation;
• No preoperative GHD, neuropsychological disorders, or other systemic diseases affecting growth or neurodevelopment.

Exclusion Criteria:

• Preoperative diagnosis of GHD, cognitive impairment, or emotional disorders;
• Concurrent intracranial tumors or systemic diseases (e.g., congenital growth hormone deficiency, Down syndrome);
• Loss to follow-up or incomplete clinical data;
• Tumor recurrence requiring reoperation during follow-up.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Grade 0; Hypothalamic Injury Uninvolved (n=100)
Grade 1; Mild Compression (n=250)
Grade 2; Significant Invasion (n=150)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of growth hormone deficiency (GHD) at 2 years post-surgery	defined as peak GH < 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in height standard-deviation score (Δ-height SDS) from baseline to final follow-up.	2 years
Proportion of patients who initiate recombinant human GH (rhGH) therapy	2 years
Normalized IGF-1 level (age-/sex-adjusted z-score) at final follow-up.	2 years
Mean full-scale IQ score (WISC-IV) and rate of cognitive impairment (IQ < 85).	2 years

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: December 24, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Neuropsychological Development; Hypothalamic Injury; Stratified Nursing Pathway; Multicenter Retrospective Study
• Additional Relevant MeSH Terms: Endocrine System Diseases; Bone Diseases; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Histologic Type; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Hypothalamic Diseases; Pituitary Diseases; Bone Diseases, Endocrine; Bone Diseases, Developmental; Dwarfism; Hypopituitarism; Craniopharyngioma; Dwarfism, Pituitary
• Other Study ID Numbers: WestChinaH-HX-2025-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No