Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Prospective and randomized evaluate efficiency and safety of different treatment strategies for hypothalamus-invading pituitary adenomas (HIPA)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIPA group of Puget grade 1 | Experimental | the tumor abuting or displacing the hypothalamus in the preoperative MR images |
|
| HIPA group of Puget grade 2 | Experimental | hypothalamic involvement (the hypothalamus is no longer identifiable) in the preoperative MR images |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total resection | Procedure | Total resection of HIPA in a single surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of QoL (Quality of Life, EQ-5D) for the first surgery | EQ-5D will be evaluated before the first surgery and after the first surgery in 2 years | baseline (before the first surgery), 2 years after the first surgery |
| Change of QoL (Quality of Life, EQ-5D) for the second intervention | EQ-5D will be evaluated before the second intervention and after the second intervention in 3 months | baseline (before the second intervention), 3 months after the second intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Visual Acuity statue | Visual Acuity statue will be evaluated using Snellen's chart before the first surgery and after the first surgery in 2 years | baseline (before the first surgery), 2 years after the first surgery |
| Change of Visual Field statue |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Huang, PhD, MD | Contact | 027-85350819 | neuroht@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tao Huang, PhD, MD | Department of Neurosurgery, Union hospital, Huazhong University of Science and Technology | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Staged resection | Procedure | HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date |
|
| Subtotal resection followed by stereotactic radiation therapy | Procedure | HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy |
|
Visual Field statue will be evaluated using a Humphrey visual field analyser before the first surgery and after the first surgery in 2 years |
| baseline (before the first surgery), 2 years after the first surgery |
| Change of Hormone Replacement Therapy | Whether the Hormone Replacement Therapy was used (Yes or No) before the first surgery and after the first surgery in 2 years | baseline (before the first surgery), 2 years after the first surgery |
| Extent of resection | 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. | baseline (before the first surgery), 2 years after the first surgery |
| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
| D015173 | Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided