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Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma

S

Sichuan University

Status

Completed

Conditions

Craniopharyngioma
Growth Hormone Deficiency (GHD)

Study type

Observational

Funder types

Other

Identifiers

NCT07342686
WestChinaH-HX-2025-07

Details and patient eligibility

About

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.

Enrollment

500 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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.

Trial design

500 participants in 3 patient groups

Grade 0
Description:
Hypothalamic Injury Uninvolved (n=100)
Grade 1
Description:
Mild Compression (n=250)
Grade 2
Description:
Significant Invasion (n=150)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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