Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

• Conditions: Craniopharyngioma
• Interventions: Procedure: Different surgical approach and techniques being used to treat three subtype of CP

• Registration Number: NCT00949156
• Lead Sponsor: Southern Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-29
• Study First Posted: 2009-07-30
• Primary Completion: 2009-10
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-14
• Last Update Posted: 2010-09-15
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 238

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective cohort	Different surgical approach and techniques being used to treat three subtype of CP	The anticipated 40 cases of CP were surgical treated by our standard procedure, which is recruited in the prospective cohort. With the long-term follow up, QOL including the cognition, circadian rhythm, endocrine, Water-Electrolyte, and body weight et al were evaluated to assess the rationality of the treatment. Then according to the results, the surgical treatment was modified, and the endocrinic substitution therapy was also been developed.

Primary Outcome Measures

Name	Time	Method
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.	1~2 years
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.	1~2 years
After long term follow up of CP patients, the normalized treatment was evaluated and modified.	3~5 years

Trial Locations

Locations (1)

Neurosurgery department, Nanfang hospital; 🇨🇳 Guangzhou, Guangdong, China