Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

Zhejiang University

Status: Not yet enrolling

Conditions: Pituitary Tumor

Treatments: Drug: Bromocriptin 2.5mg, 2-3 times a day; Procedure: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06556186

2024-0268

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Operation group

Experimental group

Description:

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Treatment:

Procedure: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Drug group

Active Comparator group

Description:

Bromocriptin 2.5mg, 2-3 times a day

Treatment:

Drug: Bromocriptin 2.5mg, 2-3 times a day