growth hormone pituitary adenoma
Conditions
Interventions
Preoperative medication group:Preoperative medication
Surgical treatment group:Directly surgical treatment
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Both men and women, aged from 18 to 60 years; 2. Serum random GH level greater than 2.5 ng/ml; 3. Imaging examination confirmed space-occupying lesions in the pituitary region; 4. Imaging showed no tumor invasion of the surrounding dura mater and bone. The tumor shape was relatively regular, without surrounding or protruding into the cavernous sinus, and no local bone destruction or absorption; 5. Imaging and clinical physical examination confirmed that elevated GH was associated with pituitary mass lesions; 6. Subject has given a written (personally signed and dated) informed consent form prior to proceeding with any study related procedures.
Exclusion criteria
Exclusion criteria: 1. The subject's skull received radiotherapy; 2. Surgical treatment for pituitary lesions; 3. used SSA drugs within 1 month before screening; 4. Traditional Chinese medicine treatment for pituitary adenoma was used within 1 month before screening; 5. According to the clinical judgment, the subject has serious visual and visual field changes and must undergo surgery to relieve the compression of the optic chiasma within a time limit; 6. Subjects are not suitable for MRI examination of pituitary adenoma; 7. During the 6 months of screening, subjects developed the following symptoms: myocardial infarction, severe/unstable angina pectoris, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, or hypertension that is not well controlled by current medications; 8. Subjects have a history of or are currently suffering from clinically significant ventricular or atrial arrhythmias (grade >=2, according to the National Cancer Institute Criteria for Common Adverse Events (NCI CTCAE) V4.0); 9. Any other serious, acute or chronic health problems or mental illness or any abnormal laboratory results; 10. Diabetic patients with poor control (HbA1c >8.5%); 11. Subjects with any malignant disease, except those who have not developed the disease for at least 5 years after treatment for cervical cancer; 12. subjects with sinus bradycardia, untreated pathological sinus node syndrome, and atrioventricular block; 13. Subject had clinically significant renal (creatinine >1.5 ULN) or hepatic (liver enzyme >2.5 ULN) abnormalities or any other dysfunction, as determined by the investigator; 14. Subjects have any psychiatric conditions that prevent them from understanding the nature, scope and possible consequences of the study; 15. Subjects received any other study medication during the 90 days prior to the screening visit and/or expected to receive it during the study; 16. Subjects are allergic to, or have side reactions to, study DA drugs or drugs with similar chemical structures; 17. Subjects will likely need to use contraindicated drugs during the study (screening period to the last study visit); 18. The subject has a history of alcohol and/or drug abuse; 19. Subject is pregnant or lactating; 20. Coagulation dysfunction; 21. Complicated with malignant diseases or other systemic diseases that seriously affect the activities, functions and quality of life of patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| growth hormone; | — |
Secondary
| Measure | Time frame |
|---|---|
| cost effectiveness ratio;recurrence time;drug resistance rate;pituitary function;QALY of Arco; | — |
Countries
China
Contacts
Public ContactChen Wenli
the First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed