Overview

This trial is active, not recruiting.

Condition craniopharyngioma
Treatment different surgical approach and techniques being used to treat three subtype of cp
Phase phase 1
Sponsor Southern Medical University, China
Start date September 1997
End date October 2009
Trial size 238 participants
Trial identifier NCT00949156, SMUneurosurgery

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
The 198 cases of CP with primary surgery in our hospital (since July, 1997 until now) were divided into three topographical groups based on the pre-operative MRI, intraoperative findings and the tumor-membrane relationship. The presurgical manifestation, the different surgical approach, intraoperative techniques, and postoperative complication were described and analyzed to establish a normalized surgical treatment of individual CP patient, which has the highest rate of the totally tumoral resection and the lowest rate of the hypothalamic injury.
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.
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.

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.
time frame: 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.
time frame: 1~2 years
After long term follow up of CP patients, the normalized treatment was evaluated and modified.
time frame: 3~5 years

Eligibility Criteria

Male or female participants from 1 year up to 70 years old.

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.

Additional Information

Official title Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
Principal investigator Songtao Qi, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Southern Medical University, China.