Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement

Study Purpose

Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement.

- Informed consent.

Exclusion Criteria:

- No follow-up possible.

- Emergency surgery without informed consent

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04863456
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Wuhan Union Hospital, China
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Tao Huang, PhD, MD
Principal Investigator Affiliation	Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Adenoma

Additional Details

There are various treatment strategies for hypothalamus-invading pituitary adenomas (HIPA), such as total resection (TR), subtotal resection with radiosurgery (STR+RS), etc. However,the optimal treatment of HIPA is still controversial. In this study, we want to evaluate the efficiency and safety of different treatment strategies in adults with HIPA.

Arms & Interventions

Arms

Experimental: HIPA group of Puget grade 1

the tumor abuting or displacing the hypothalamus in the preoperative MR images

Experimental: HIPA group of Puget grade 2

hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images

Interventions

Procedure: - Total resection

Total resection of HIPA in a single surgery

Procedure: - Staged resection

HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date

Procedure: - Subtotal resection followed by stereotactic radiation therapy

HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Tao Huang, PhD, MD

[email protected]

027-85350819

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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