Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

NCT ID: NCT06556186

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pituitary Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Operation group

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Group Type EXPERIMENTAL

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Intervention Type PROCEDURE

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Drug group

Bromocriptin 2.5mg, 2-3 times a day

Group Type ACTIVE_COMPARATOR

Bromocriptin 2.5mg, 2-3 times a day

Intervention Type DRUG

Bromocriptin 2.5mg, 2-3 times a day

Interventions

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Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Intervention Type PROCEDURE

Bromocriptin 2.5mg, 2-3 times a day

Bromocriptin 2.5mg, 2-3 times a day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Qun Wu, Doctor

Role: CONTACT

+86-13605810393

Other Identifiers

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2024-0268

Identifier Type: -

Identifier Source: org_study_id

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