A Hypothalamic Injury-Stratified Nursing Care Pathway for Pediatric Craniopharyngioma Survivors: Advancing Nursing Leadership in Complex Chronic Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of growth hormone deficiency (GHD) at 2 years post-surgery
研究概览
简要总结
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:
- 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?
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Grade 0
Hypothalamic Injury Uninvolved (n=100)
Grade 1
Mild Compression (n=250)
Grade 2
Significant Invasion (n=150)
结局指标
主要结局
Incidence of growth hormone deficiency (GHD) at 2 years post-surgery
时间窗: 2 years
defined as peak GH \< 10 ng/mL on stimulation testing plus age-/sex-adjusted IGF-1 below reference range
次要结局
- 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)
研究者
Zhigang Lan
Professor
West China Hospital
