Surgical and Pharmacological Efficacy of Knosp Grade 0-2 Prolactinoma

August 13, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Operation group
Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy
Procedure: Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy
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
Bromocriptin 2.5mg, 2-3 times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pituitary hormone levels
Time Frame: At 1, 3, 6, 9 and 12 months postoperatively
Recheck pituitary hormones (PRL, GH, ACTH, etc.)
At 1, 3, 6, 9 and 12 months postoperatively
pituitary MRI
Time Frame: At 1,6 and 12 months postoperatively
Recheck pituitary MRI
At 1,6 and 12 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sexual function evaluation
Time Frame: At 1,6 and 12 months postoperatively
Male:International Index of Erectile Function (IIEF-5); Female:Female Sexual Function Index (FSFI)
At 1,6 and 12 months postoperatively
menstrual condition
Time Frame: At 6 and 12 months postoperatively
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
At 6 and 12 months postoperatively
lactation
Time Frame: At 1,6 and 12 months postoperatively
Serum prolactin levels
At 1,6 and 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Peking Union Medical College Hospital
West China Hospital
Ningbo Medical Center Lihuili Hospital
First Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0268

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pituitary Tumor

Clinical Trials on Transnasal transsphenoidal pituitary lesion resection under neuroendoscopy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe