Working… Menu

Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949156
Recruitment Status : Unknown
Verified September 2010 by Southern Medical University, China.
Recruitment status was:  Active, not recruiting
First Posted : July 30, 2009
Last Update Posted : September 15, 2010
Information provided by:
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.

Condition or disease Intervention/treatment
Craniopharyngioma Procedure: Different surgical approach and techniques being used to treat three subtype of CP

Layout table for study information
Study Type : Observational
Estimated Enrollment : 238 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma
Study Start Date : September 1997
Actual Primary Completion Date : October 2009
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Retrospective cohort
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.
Prospective cohort
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.
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.

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. After long term follow up of CP patients, the normalized treatment was evaluated and modified. [ Time Frame: 3~5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949156

Layout table for location information
China, Guangdong
Neurosurgery department, Nanfang hospital
Guangzhou, Guangdong, China, 510515
Sponsors and Collaborators
Southern Medical University, China
Layout table for investigator information
Principal Investigator: Songtao Qi, MD, PhD Director, Neurosurgery department, Nanfang Hospital

Layout table for additonal information
Responsible Party: Qi Songtao, Southern Medical University, China Identifier: NCT00949156     History of Changes
Other Study ID Numbers: SMUneurosurgery
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: September 15, 2010
Last Verified: September 2010
Keywords provided by Southern Medical University, China:
Membranous structure
Pituitary stalk
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases