Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06556186

Enrollment

600

Registered

2024-08-15

Start date

2024-10-01

Completion date

2027-03-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pituitary Tumor

Keywords

pituitary tumor

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.

Interventions

PROCEDURETransnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

DRUGBromocriptin 2.5mg, 2-3 times a day

Bromocriptin 2.5mg, 2-3 times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Prolactin level greater than three times the normal upper limit * MRI indicates Knosp Grade 0-2 pituitary adenoma

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
pituitary hormone levels	At 1, 3, 6, 9 and 12 months postoperatively	Recheck pituitary hormones (PRL, GH, ACTH, etc.)
pituitary MRI	At 1,6 and 12 months postoperatively	Recheck pituitary MRI

Secondary

Measure	Time frame	Description
sexual function evaluation	At 1,6 and 12 months postoperatively	Male:International Index of Erectile Function (IIEF-5); Female:Female Sexual Function Index (FSFI)
menstrual condition	At 6 and 12 months postoperatively	There is currently no specific Pituitary Tumor Menstrual Status Questionnaire for evaluation. The investigators usually evaluate the impact of pituitary tumors on menstruation based on the participants clinical symptoms and the results of sex hormones
lactation	At 1,6 and 12 months postoperatively	Serum prolactin levels

Contacts

Primary ContactQun Wu, Doctor

2192010@zju.edu.cn+86-13605810393

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026