Efficiency and Safety of Different Treatment Strategies in Adults With Pituitary Adenomas With Hypothalamic Involvement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Primary Endpoint
- Change of QoL (Quality of Life, EQ-5D) for the second intervention
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Change of QoL (Quality of Life, EQ-5D) for the second intervention
Time Frame: 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
Time Frame: 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 Outcomes
- Change of Hormone Replacement Therapy(baseline (before the first surgery), 2 years after the first surgery)
- Change of Visual Acuity statue(baseline (before the first surgery), 2 years after the first surgery)
- Extent of resection(baseline (before the first surgery), 2 years after the first surgery)
- Change of Visual Field statue(baseline (before the first surgery), 2 years after the first surgery)