Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma

NCT ID: NCT07342686

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2023-12-30

Brief Summary

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.

Conditions

Craniopharyngioma; Growth Hormone Deficiency (GHD)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Grade 0

Hypothalamic Injury Uninvolved (n=100)

No interventions assigned to this group

Grade 1

Mild Compression (n=250)

No interventions assigned to this group

Grade 2

Significant Invasion (n=150)

No interventions assigned to this group

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhigang Lan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

WestChinaH-HX-2025-07

Identifier Type: -

Identifier Source: org_study_id