The purpose of this study is to observe whether dopamine agonists can be safely withdrawn after the tumor volume and prolactin level of invasive prolactinomas involving the cavernous sinus have been effectively controlled through pharmacological treatment.
For giant or large invasive prolactinomas involving the cavernous sinus, whether the drug can be safely withdrawn after the tumor volume and prolactin(PRL) level have been effectively controlled through pharmacological treatment still remains unknown. The study objects are patients with invasive prolactinomas involving the cavernous sinus, which were invaded the cavernous sinus to an extent corresponding to Grade III or IV, according to the classification scheme of Knosp and colleagues, who had undergone pharmacological treatment including bromocriptine or cabergoline. Observation will be started after drug withdrawal criteria are reached (PRL remains normal level for no less than two years; tumor volume has shrank more than 50%, and the distance is more than 5mm between tumor and optical nerve),the patients are randomized to withdrawal group or continue treatment group.Observational items include changes of PRL level, tumor volume as well as vision acuity and visual fields. If elevated PRL or tumor relapse is observed, pharmacological treatment will be restarted.
Study Type
OBSERVATIONAL
Enrollment
30
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGXinqiao Hospital of Chongqing
Change from baseline on PRL level
Record the result of PRL on every 3 month follow-up visit
Time frame: Up to 2 years
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging(MRI)
Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
Time frame: Up to 2 years
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit
Time frame: Up to 2 years
Change from baseline on 5 point visual field scale
Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind
Time frame: Up to 2 years
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Chongqing, Chongqing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGRuijin Hosipital
Shanghai, Shanghai Municipality, China
ENROLLING_BY_INVITATIONHuashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGFirst Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITING