Clinical trial NCT00949156: Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
Official title: Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Craniopharyngioma
Keywords: Craniopharyngiomas
Classification
Membranous structure
Pituitary stalk
Obesity
panhypopituitarism
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2009-07-30
Enrollment: 238
Sex: ALL
Minimum age (years): 1
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The clinical data of 198 patients who underwent primary microsurgery for craniopharyngiomas at our institute since July, 1997 until now was analysed retrospectively. The anticipated 40 CP patients in the following two years were recurited in the prospective cohort, who will be surgical treated according to the standard process.

Brief summary: With the preliminary anatomical and histological study, the membranous structures of the sellar region was considered to be closely related with the growth pattern of Craniopharyngiomas(CP). By combined considering of the tumor-membrane relationship, this project was trying to classify the CP through retrospectively summarizing the pre- and postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 198 CPs with primary surgery in our hospital (since 1997 until now). As a result, a distinct and systematic CP classification was proposed. The possible originate site, surgical skills and postoperative treatment of all the subtype tumors were discussed and analyzed to provide a normalized surgical treatment for this kind of tumor. Then in the prospective cohort, the anticipated 100 CP patients will accept the normalized surgical treatment. And by the long term follow up, the postsurgical quantity of life (QOL) of patients was evaluated with aspect in cognition, circadian rhythm, endocrine, Water-Electrolyte and body weight, et al. By comparing with the long-term results of the retrospective cohort, the totally follow up data was statistically analyzed to assess the rationality of this standard treatment of CP.


Eligibility criteria: Inclusion Criteria:

1. Primary craniopharyngioma(initial diagnosis);
2. The sufficient pre-, intra and postoperative information (including patient's information, presenting manifestation, the pre- and postsurgical MRI, CT; Intrasurgical image, and endocrine data);
3. After surgery, patients are followed periodically. Quality of life is assessed at baseline and then periodically thereafter.

Primary outcomes:
measure: The course of suprasellar arachnoid mater and pia mater, and the construction of all meninges of the sellar region was observed and measured by microscopy.
timeFrame: 1~2 years
measure: Through the analysis of the pre- and postoperative imaging and intrasurgical findings of CP, and combined considering of the tumor-membrane relationship, the classification of CP was proposed.
timeFrame: 1~2 years
measure: After long term follow up of CP patients, the normalized treatment was evaluated and modified.
timeFrame: 3~5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Neurosurgery department, Nanfang hospital
state: Guangdong
Study officials:
affiliation: Director, Neurosurgery department, Nanfang Hospital
name: Songtao Qi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peng JX, Yang L, Huang GL, Liu Y, Zhang SC, Pan J, Qi ST. Development of a novel score to predict probability of growth without growth hormone after resection of paediatric craniopharyngiomas: relative to tumour growth pattern. J Endocrinol Invest. 2020 Jun;43(6):737-747. doi: 10.1007/s40618-019-01154-y. Epub 2019 Dec 18.