Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

N/ANot Yet RecruitingNCT06556186

Second Affiliated Hospital, School of Medicine, Zhejiang University600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

600

Conditions

Pituitary Tumor

Interventions

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

pituitary hormone levels

Recheck pituitary hormones (PRL, GH, ACTH, etc.)

Time frame: At 1, 3, 6, 9 and 12 months postoperatively

pituitary MRI

Recheck pituitary MRI

Time frame: At 1,6 and 12 months postoperatively

Secondary Outcomes

sexual function evaluation

Male:International Index of Erectile Function (IIEF-5); Female:Female Sexual Function Index (FSFI)

Time frame: At 1,6 and 12 months postoperatively

menstrual condition

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

Time frame: At 6 and 12 months postoperatively

lactation

Serum prolactin levels

Time frame: At 1,6 and 12 months postoperatively

Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts