Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2018
INTERVENTION: 3 hours before operation, patients will take the 5‐aminolevulinic acid(20 mg/kg) once. 3 hours later, they will be performed photodynamic diagnosis under the hysteroscopy. During the operation, they will be observed with the white light first. After that, they will be observed with the excitation light. We will record all lesions and we will judge whether the lesion is positive, weakly positive or negative for the photodynamic diagnosis. After judgement, we will resect positive and weakly positive lesions under the excitation light first. After that, we'll resect other lesions under the white light if we can find any in addition. When the resection is finished, we will do curettage if we need. We will investigate all samples histopathologically. CONDITION: diseases in the uterine cavity (ex: uterine myoma, endometrial polyp, uterine corpus cancer, endometrial hyperplasia) PRIMARY OUTCOME: Diagnostic accuracy of the hysteroscopic photodynamic diagnosis using 5‐ALA for malignant diseases. SECONDARY OUTCOME: The relation of the histologic type and the strength of the fluorescence. INCLUSION CRITERIA: Patients who have diseases in the uterine cavity (including both of benign and malignant). Patients who plan to undergo hysteroscopic operation for those diseases at the Department of Obstetrics and Gynecology of Keio University Hospital
Epistemonikos ID: c794a2e90397fa4172268212809f98ebf0b2c30d
First added on: Aug 24, 2024