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临床试验/NCT07342686
NCT07342686已完成不适用

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

West China Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年12月1日最近更新:
适应症

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:

  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.

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhigang Lan

Professor

West China Hospital

研究点 (1)

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