NCT00949156

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1997

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 15, 2010

Status Verified

September 1, 2010

Enrollment Period

12.1 years

First QC Date

July 21, 2009

Last Update Submit

September 14, 2010

Conditions

Keywords

CraniopharyngiomasClassificationMembranous structurePituitary stalkObesitypanhypopituitarism

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • After long term follow up of CP patients, the normalized treatment was evaluated and modified.

    3~5 years

Study Arms (2)

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

Interventions

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.

Prospective cohort

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurosurgery department, Nanfang hospital

Guangzhou, Guangdong, 510515, China

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

CraniopharyngiomaObesityCombined Pituitary Hormone Deficiency

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Songtao Qi, MD, PhD

    Director, Neurosurgery department, Nanfang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 30, 2009

Study Start

September 1, 1997

Primary Completion

October 1, 2009

Study Completion

December 1, 2015

Last Updated

September 15, 2010

Record last verified: 2010-09

Locations