Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 40 Years
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06556186
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pituitary Tumor

Arms & Interventions

Arms

Experimental: Operation group

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Active Comparator: Drug group

Bromocriptin 2.5mg, 2-3 times a day

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Qun Wu, Doctor

[email protected]

+86-13605810393

For additional contact information, you can also visit the trial on clinicaltrials.gov.

Clinical Trial Finder