Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
- Conditions
- Pituitary Adenoma
- Registration Number
- NCT04863456
- Lead Sponsor
- Wuhan Union Hospital, China
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Suspected symptomatic or progressively growing pituitary adenoma with Hypothalamic Involvement
- Informed consent
- No follow-up possible
- Emergency surgery without informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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
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
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.
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