Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

Craniopharyngioma Clinical Trial

Official title:

Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00949156
• Other study ID #: SMUneurosurgery
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 21, 2009
• Last updated: September 14, 2010
• Start date: September 1997
• Est. completion date: December 2015

Study information

• Verified date: September 2010
• Source: Southern Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 238
• Est. completion date: December 2015
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Craniopharyngioma

Intervention

Procedure:
• Different surgical approach and techniques being used to treat three subtype of CP
According to the presurgical MRI, with the analysis of the morphological characteristic of three subtype of CP, different surgical approach and intrasurgical skills were used to treat tumors with trying to total remove tumor and avoid the hypothalamus injury.

Locations

Country	Name	City	State
China	Neurosurgery department, Nanfang hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	After long term follow up of CP patients, the normalized treatment was evaluated and modified.		3~5 years	Yes