Hypothalamic-Stratified Nursing Pathway for Pediatric Craniopharyngioma

NCT07342686 | Completed DMC

• 1 other identifier: WestChinaH-HX-2025-07
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 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. 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?

Conditions

Craniopharyngioma; Growth Hormone Deficiency (GHD)

Keywords

Hypothalamic Injury; Neuropsychological Development; Stratified Nursing Pathway; Multicenter Retrospective Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

Grade 0

Hypothalamic Injury Uninvolved (n=100)

Grade 1

Mild Compression (n=250)

Grade 2

Significant Invasion (n=150)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Craniopharyngioma; Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 15, 2026
• Study Start: December 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 15, 2026

Record last verified: 2013-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)