This study evaluates the efficacy and safety of ALA-PDT versus LEEP in treating cervical HSIL/CIN2, aiming to demonstrate non-inferiority in clinical efficacy.
This study aims to conduct a multicenter, prospective, concurrent non-controlled clinical trial to evaluate the clinical efficacy of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) compared with loop electrosurgical excision procedure (LEEP) in patients with high-grade squamous intraepithelial lesion (HSIL/CIN2), using a non-inferiority design. The primary objective is to demonstrate that ALA-PDT is non-inferior to LEEP with respect to key efficacy endpoints. Furthermore, the safety profiles, cervical tissue regeneration outcomes, and long-term prognoses of both treatment modalities will be comprehensively assessed. The results are anticipated to provide robust clinical evidence supporting ALA-PDT as a safer, less invasive, and function-preserving alternative for the management of HSIL/CIN2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
560
Apply 20% ALA gel for 3 hours, followed by red light irradiation, repeated every 7-14 days for a total of 6-9 sessions.
After anesthesia, cervical iodine staining was performed, followed by LEEP.
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, China
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Hangzhou Linping District first People's Hospital
Hangzhou, Zhejiang, China
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Lesion effective rate
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 6 months post-treatment as the primary endpoint.
Time frame: 6 months
Lesion effective rate
Proportion of patients with LSIL or normal histopathology on colposcopy-guided cervical biopsy, assessed at 12 and 24 months post-treatment.
Time frame: 2 years
HPV clearance rate
HPV clearance rates at 3, 6, 9, 12, and 24 months post-treatment
Time frame: 2 years
Lesion cure rate
Proportion of patients with normal colposcopy-guided cervical biopsy results and negative HPV
Time frame: 2 years
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Shaoxing People's Hospital
Shaoxing, Zhejiang, China