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Not yet recruiting NCT06556186

Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

No phase Interventional Pituitary Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy, Bromocriptin 2.5mg, 2-3 times a day.
Who it may be relevant to
Registry conditions: Pituitary Tumor. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

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

Primary outcome measures

  • pituitary hormone levels [Time frame: At 1, 3, 6, 9 and 12 months postoperatively]
  • pituitary MRI [Time frame: At 1,6 and 12 months postoperatively]
Secondary outcome measures (3)
  • sexual function evaluation [Time frame: At 1,6 and 12 months postoperatively]
  • menstrual condition [Time frame: At 6 and 12 months postoperatively]
  • lactation [Time frame: At 1,6 and 12 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06556186 · 2024-0268

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗