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Not yet recruitingNCT06556186Updated Aug 15, 2024

Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

An interventional study of Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy and Bromocriptin 2.5mg, 2-3 times a day in Pituitary Tumor, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Pituitary Tumor

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Keywords

  • pituitary tumor
03

In context

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

This study's planned enrollment of 600 is above the median of 60 across 121 interventional studies indexed under Pituitary Neoplasms.

Browse Pituitary Neoplasms studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Prolactin level greater than three times the normal upper limit
  • MRI indicates Knosp Grade 0-2 pituitary adenoma

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Operation group

    Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

    Procedure: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

  • Active comparator
    Drug group

    Bromocriptin 2.5mg, 2-3 times a day

    Drug: Bromocriptin 2.5mg, 2-3 times a day

Interventions

  • ProcedureTransnasal transsphenoidal pituitary lesion resection under neuroendoscopy

    Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

  • Bromocriptin 2.5mg, 2-3 times a day

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Mar 2027, 29 months later.

Of 46 interventional studies with no phase under Pituitary Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 29 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2024
First posted
Aug 15, 2024
StartEst.
Oct 1, 2024
Primary completionEst.
Mar 31, 2027
CompletionEst.
Mar 31, 2027
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06556186
Collaborators
Peking Union Medical College Hospital, West China Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo Medical Center Lihuili Hospital
Responsible party
Sponsor
First posted
Aug 15, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Mar 31, 2027 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Aug 15, 2024

Study contacts

Qun Wu, Doctor
Contact
2192010@zju.edu.cn
+86-13605810393

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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