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NCT Number: NCT06556186

Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

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.

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Key information

Conditions

Pituitary Tumor Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Procedure

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Bromocriptin 2.5mg, 2-3 times a day

Drug

Bromocriptin 2.5mg, 2-3 times a day

Primary outcomes

  1. pituitary hormone levels

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

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

  2. pituitary MRI

    Time frame: At 1,6 and 12 months postoperatively

    Recheck pituitary MRI

Secondary outcomes

  1. sexual function evaluation

    Time frame: At 1,6 and 12 months postoperatively

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

  2. menstrual condition

    Time frame: 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

  3. lactation

    Time frame: At 1,6 and 12 months postoperatively

    Serum prolactin levels

Study contacts

Contact information is provided by the study sponsor or research team.

Qun Wu, Doctor

CONTACT

[email protected]

+86-13605810393

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • Ningbo Medical Center Lihuili Hospital
  • Peking Union Medical College Hospital
  • West China Hospital

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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