Pituitary Adenoma
Conditions
Keywords
pituitary adenoma, treatment strategy, Hypothalamus
Brief summary
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)
Detailed description
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.
Interventions
PROCEDURETotal resection
Total resection of HIPA in a single surgery
PROCEDUREStaged resection
HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date
PROCEDURESubtotal resection followed by stereotactic radiation therapy
HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of QoL (Quality of Life, EQ-5D) for the first surgery | baseline (before the first surgery), 2 years after the first surgery | EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years |
| Change of QoL (Quality of Life, EQ-5D) for the second intervention | baseline (before the second intervention), 3 months after the second intervention | EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Visual Acuity statue | baseline (before the first surgery), 2 years after the first surgery | Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years |
| Change of Visual Field statue | baseline (before the first surgery), 2 years after the first surgery | Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years |
| Change of Hormone Replacement Therapy | baseline (before the first surgery), 2 years after the first surgery | Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years |
| Extent of resection | baseline (before the first surgery), 2 years after the first surgery | Volumetric analysis of tumor volume before the first surgery, intraoperatively and 3 months and 2 years after the first surgery will be performed. In addition, Tumor volume will be evaluated before the second intervention and intraoperatively. Gross total resection is defined as no tumor present in gadolinium enhanced T1 sequences. |
Contacts
Primary ContactTao Huang, PhD, MD
Outcome results
None listed