Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma - Full Text View

Sponsor:	Southern Medical University, China
Information provided by:	Southern Medical University, China
ClinicalTrials.gov Identifier:	NCT00949156

Purpose

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 with retrospectively summarizing the pre- and postoperative imaging (MRI and CT), the intrasurgical findings, and the endocrine data of 268 CP cases (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.

Condition	Intervention	Phase
Craniopharyngioma	Procedure: Different surgical approach and techniques being used to treat three subtype of CP	Phase I

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by Southern Medical University, China:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
After long term follow up of CP patients, the normalized treatment was evaluated and modified. [ Time Frame: 3~5 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Estimated Enrollment:	368
Study Start Date:	September 1997
Estimated Study Completion Date:	December 2015
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Retrospective cohort The 268 cases of CP (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.
Prospective cohort The anticipated 100 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.	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.

Groups/Cohorts

Assigned Interventions

Retrospective cohort

The 268 cases of CP (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.

Prospective cohort

The anticipated 100 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.

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.

Eligibility

Ages Eligible for Study:	1 Year to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The clinical data of 268 patients who underwent primary microsurgery for craniopharyngiomas at our institute since July, 1997 until now was analysed retrospectively. The anticipated 100 CP patients in the following two years were recurited in the prospective cohort, who will be surgical treated according to the standard process.

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949156

Locations

China, Guangdong
Neurosurgery department, Nanfang hospital
Guangzhou, Guangdong, China, 510515

Sponsors and Collaborators

Southern Medical University, China

Investigators

Principal Investigator:

Songtao Qi, MD, PhD

Director, Neurosurgery department, Nanfang Hospital

More Information

No publications provided

Responsible Party:	Southern Medical University, China ( Qi Songtao )
Study ID Numbers:	SMUneurosurgery
Study First Received:	July 21, 2009
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00949156 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Southern Medical University, China:

Craniopharyngiomas
Classification
Membranous structure

Pituitary stalk
Obesity
panhypopituitarism

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Craniopharyngioma

ClinicalTrials.gov processed this record on November 20, 2009