Extramammary Paget's Disease
Conditions
Interventions
Extended resection group:Under local anesthesia, general anesthesia or lumbar anesthesia, 2cm along the edge of the skin lesion visible to the naked eye as the cutting edge, complete excision of all t
Narrow margin resection combined with ALA-PDT group:?Narrow margin excision: under local anesthesia, general anesthesia or lumbar anesthesia, according to the actual lesion site along the edge of the
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1Pathologic diagnosis of EMPD, age 40-80 years old (including 40 years old and 80 years old), male and female; 2Voluntary acceptance of surgical treatment, and agree to take photographs of the skin lesions; 3No serious hematopoietic and coagulation function abnormality and heart, lung, liver, kidney function abnormality and immunodeficiency; 4Subjects with expected survival time > 3 months; 5, for the clinical trial drug (5-amino ketoglutarate bulk, ALA) and the purpose and content of this clinical trial (including subjects to comply with matters, etc.) to give a full explanation, based on full understanding, voluntarily sign the informed consent to participate in the clinical trial.
Exclusion criteria
Exclusion criteria: 1, known allergy to the test drug or light; 2, receiving other anti-tumor drugs (radiotherapy, immunotherapy, etc.) simultaneously during the treatment of this trial; 3, Combined serious diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension and so on; 4, subjects with acute inflammation or clinically significant active infection; 5, Pregnant or lactating women, and subjects (including men) of childbearing age who refuse to use adequate contraception during the study; 6, Subjects in a malignant state, or subjects in advanced stages who are assessed to be unable to tolerate photodynamic therapy; 7, Subjects with severe physical or mental illness that, in the opinion of the investigator, may interfere with treatment, evaluation, or poor compliance with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relapse rate; | — |
Countries
China
Contacts
Public ContactWang Xiuli
Shanghai Skin Disease Hospital
Outcome results
None listed