Health TrialsbyHealthPanel

Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

ConditionPituitary Tumor
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Prolactin level greater than three times the normal upper limit

MRI indicates Knosp Grade 0-2 pituitary adenoma

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

    Procedure/Surgery

    Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

  • Bromocriptin 2.5mg, 2-3 times a day

    Drug

    Bromocriptin 2.5mg, 2-3 times a day

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Operation groupExperimental treatment 1 intervention
Group B: Drug groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

pituitary hormone levels

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

Time frame
At 1, 3, 6, 9 and 12 months postoperatively
2

pituitary MRI

Recheck pituitary MRI

Time frame
At 1,6 and 12 months postoperatively

Secondary outcomes

1

sexual function evaluation

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

Time frame
At 1,6 and 12 months postoperatively
2

menstrual condition

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

Time frame
At 6 and 12 months postoperatively
3

lactation

Serum prolactin levels

Time frame
At 1,6 and 12 months postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Peking Union Medical College Hospital

Collaborator

West China Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: