Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
1 other identifier
interventional
600
0 countries
N/A
Brief Summary
The investigators carried out a multi-center comparative study, involving hospitals including the Second Affiliated Hospital of Zhejiang University School of Medicine, Peking Union Medical College Hospital, West China Hospital, Wenzhou First Hospital, and Li Huili Hospital. This study aimed to compare the efficacy of medication and surgery for specific subtypes of microadenomas and clearly defined macroadenomas (Knosp grades 0-2), in order to determine which is more effective and which has fewer benefits, thereby enhancing the evidence base.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2024
CompletedFirst Posted
Study publicly available on registry
August 15, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
August 15, 2024
July 1, 2024
2.5 years
August 5, 2024
August 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
pituitary hormone levels
Recheck pituitary hormones (PRL, GH, ACTH, etc.)
At 1, 3, 6, 9 and 12 months postoperatively
pituitary MRI
Recheck pituitary MRI
At 1,6 and 12 months postoperatively
Secondary Outcomes (3)
sexual function evaluation
At 1,6 and 12 months postoperatively
menstrual condition
At 6 and 12 months postoperatively
lactation
At 1,6 and 12 months postoperatively
Study Arms (2)
Operation group
EXPERIMENTALTransnasal transsphenoidal pituitary lesion resection under neuroendoscopy
Drug group
ACTIVE COMPARATORBromocriptin 2.5mg, 2-3 times a day
Interventions
Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy
Eligibility Criteria
You may qualify if:
- Prolactin level greater than three times the normal upper limit
- MRI indicates Knosp Grade 0-2 pituitary adenoma
You may not qualify if:
- MRI indicates Knosp grade 3-4 pituitary adenoma
- Taking antidepressants or other psychotropic drugs
- Patients allergic to bromocriptine or cannot tolerate surgery
- Women defined as surgical infertility (i.e. hysterectomy, bilateral salpingectomy, or bilateral oophorectomy), or amenorrhea for more than 2 years
- Critical illness patients, such as those with progressive consciousness disorders, cerebral hernias, and other emergency situations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2024
First Posted
August 15, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
August 15, 2024
Record last verified: 2024-07