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The Impact of Fluorescence Marking-Assisted Surgery on Surgical Margins and Disease Prognosis in Female Patients with Vulvar Paget's Disease

The Impact of Fluorescence Marking-Assisted Surgery on Surgical Margins and Disease Prognosis in Female Patients with Vulvar Paget's Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105297
Enrollment
Unknown
Registered
2025-07-01
Start date
2025-03-03
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Extramammary Paget's disease (EMPD)

Interventions

Test group:Intravenous sodium fluorescein combined with Wood's lamp irradiation for vulvar illumination to assist surgical treatment.

Sponsors

Obstetris & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with VPD through histopathological examination during the study period (either initial diagnosis or recurrence). 2. Provided written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with concurrent severe, uncontrolled systemic diseases (such as cardiac, hepatic, or renal failure) that may adversely affect surgical tolerance or recovery. 2. Patients with other concurrent primary malignancies. 3. Patients with recurrent VPD who have previously received flap transplantation surgery for the condition. 4. Patients with psychiatric disorders or cognitive impairments who cannot to comply with treatment and follow-up. 5. Patients with hypersensitivity to fluorescent labeling agents or contraindications to their administration.

Design outcomes

Primary

MeasureTime frame
Surgical Margin Status;Progression-Free Survival (PFS);

Secondary

MeasureTime frame
Overall Survival(OS);Quality of Life (QOL);Surgical Complications;

Countries

China

Contacts

Public ContactJingxin Ding

Obstetris & Gynecology Hospital of Fudan University

djxdd@sina.com+86 21 00000000

Outcome results

None listed

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