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Surgical versus drug treatment for non-invasive prolactinoma:A single-arm retrospective multi-center study

Surgical versus drug treatment for non-invasive prolactinoma:A single-arm retrospective multi-center study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093010
Enrollment
Unknown
Registered
2024-11-27
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prolactinoma

Interventions

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Diagnosis of prolactinoma: Clinical manifestations: the main manifestations of women are irregular menstruation (thin menstruation, irregular menstruation, amenorrhea, etc.), galactorrhea, repeated abortion and infertility, etc. The main manifestations of male prolactinoma are decreased libido, impotence, male mammary gland development, reduced sperm count, and even genital atrophy. Laboratory test: Prolactin level is generally greater than 150ng/ml; Imaging examination: pituitary enhanced MRI examination, etc; 2.The pituitary enhanced MRI showed clear tumor boundaries, microadenoma or non-invasive macroadenoma; 3.Age: 15-80 years old; 4.Gender: no limitation; 5.Karnofsky(KPS) scale >=70; 6.No counter-surgical evidence

Exclusion criteria

Exclusion criteria: 1.Patients with prolactinoma who have received gamma knife treatment; 2.Invasive prolactinoma: the tumor invades the surrounding tissue structures, such as the cavernous sinus, sphenoid sinus, sieve sinus, and triventricle; From the imaging evaluation, Knosp grade 3 and 4; 3.Patients who have been treated with drugs other than DAs targeting prolactinoma

Design outcomes

Primary

MeasureTime frame
Prolactin remission rate;

Secondary

MeasureTime frame
Tumor recurrence;Tumor volume;Clinical symptoms;Pituitary hormone levels;Surgical complications;Mental symptoms;Economical burden;QALYs, Quality-adjusted life years;Health-related quality of life;Additional treatment;

Countries

China

Contacts

Public ContactZhebao Wu

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

zhebaowu@aliyun.com+86 139 1804 4660

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026