MedPath

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

Not Applicable
Not yet recruiting
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
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change of QoL (Quality of Life, EQ-5D) for the second interventionbaseline (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 surgerybaseline (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
NameTimeMethod
Change of Hormone Replacement Therapybaseline (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 statuebaseline (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 resectionbaseline (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 statuebaseline (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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.