Tumor Classification and Its Application in Surgical Treatment of Craniopharyngioma

NCT ID: NCT00949156

Last Updated: 2010-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

238 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-09-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Craniopharyngioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

Different surgical approach and techniques being used to treat three subtype of CP

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Southern Medical University, China

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Southern Medical University, China

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Songtao Qi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, Neurosurgery department, Nanfang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Neurosurgery department, Nanfang hospital

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Peng JX, Yang L, Huang GL, Liu Y, Zhang SC, Pan J, Qi ST. Development of a novel score to predict probability of growth without growth hormone after resection of paediatric craniopharyngiomas: relative to tumour growth pattern. J Endocrinol Invest. 2020 Jun;43(6):737-747. doi: 10.1007/s40618-019-01154-y. Epub 2019 Dec 18.

Reference Type DERIVED
PMID: 31853886 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SMUneurosurgery

Identifier Type: -

Identifier Source: org_study_id