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Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

Zhejiang University logo

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)

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

Trial contacts and locations

0

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Central trial contact

Qun Wu, Doctor

Data sourced from clinicaltrials.gov

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