Pituitary TumorNCT06556186
Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
A study testing Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy and Bromocriptin 2.5mg, 2-3 times a day in people with Pituitary Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Pituitary Tumor
- What is being tested?
- Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy and Bromocriptin 2.5mg, 2-3 times a day
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Prolactin level greater than three times the normal upper limit
- MRI indicates Knosp Grade 0-2 pituitary adenoma
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Pituitary Tumor
- Being tested
- Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy, Bromocriptin 2.5mg, 2-3 times a day
- Keywords
- pituitary tumor
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal transsphenoidal pituitary lesion resection under neuroendoscopyProcedure or surgery
Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy
Bromocriptin 2.5mg, 2-3 times a dayDrug
Bromocriptin 2.5mg, 2-3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Operation group | Experimental | Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy Receives: Procedure: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy |
| Drug group | Active comparator | Bromocriptin 2.5mg, 2-3 times a day Receives: Drug: Bromocriptin 2.5mg, 2-3 times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
pituitary hormone levels
Recheck pituitary hormones (PRL, GH, ACTH, etc.)
Measured: At 1, 3, 6, 9 and 12 months postoperatively
pituitary MRI
Recheck pituitary MRI
Measured: At 1,6 and 12 months postoperatively
Secondary outcomes (3)
sexual function evaluation
Male:International Index of Erectile Function (IIEF-5); Female:Female Sexual Function Index (FSFI)
Measured: At 1,6 and 12 months postoperatively
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
Measured: At 6 and 12 months postoperatively
lactation
Serum prolactin levels
Measured: At 1,6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, West China Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556186
- Sponsor's protocol ID
- 2024-0268
- Status last verified
- Jul 2024
- First submitted
- 5 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma
- ClinicalTrials.gov ID
- NCT06556186
- Acronym / sponsor ID
- 2024-0268
- Conditions
- Pituitary Tumor
- Keywords
- pituitary tumor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, West China Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operation group | Experimental | Procedure: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopyTransnasal transsphenoidal pituitary lesion resection under neuroendoscopy |
| Drug group | Active comparator | Drug: Bromocriptin 2.5mg, 2-3 times a dayBromocriptin 2.5mg, 2-3 times a day |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Prolactin level greater than three times the normal upper limit
- MRI indicates Knosp Grade 0-2 pituitary adenoma
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transnasal transsphenoidal pituitary lesion resection under neuroendoscopyTransnasal transsphenoidal pituitary lesion resection under neuroendoscopy | Procedure or surgery | Operation group |
| Bromocriptin 2.5mg, 2-3 times a dayBromocriptin 2.5mg, 2-3 times a day | Drug | Drug group |
Primary outcome
pituitary hormone levels
Time frame: At 1, 3, 6, 9 and 12 months postoperatively
Recheck pituitary hormones (PRL, GH, ACTH, etc.)
pituitary MRI
Time frame: At 1,6 and 12 months postoperatively
Recheck pituitary MRI
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy and Bromocriptin 2.5mg, 2-3 times a day in people with Pituitary Tumor, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qun Wu, Doctor (+86-13605810393, 2192010@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pituitary hormone levels (time frame: At 1, 3, 6, 9 and 12 months postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.