Skip to content

Study on photodynamic therapy for patients with positive surgical margins after LEEP surgery for cervical precancerous lesions

Study on photodynamic therapy for patients with positive surgical margins after LEEP surgery for cervical precancerous lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074684
Enrollment
Unknown
Registered
2023-08-13
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Cervical intraepithelial lesion

Interventions

treatment group (5-ALA-PDT):None
control group:None

Sponsors

The International Peace Maternity & Child Health Hospital of the China Welfare Institute
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Female, aged 25-45; 2) HPV positive; 3) One week after LEEP for HSIL (CIN2, CIN3), the pathological examination showed positive HSIL margins (CIN1, CIN2, CIN3), including the outer, inner, and basal margins; 4) Preoperative colposcopy evaluation images; 5) After 3 months of LEEP surgery, there was no sexual activity, and condoms were used throughout sexual activity from 3 months after LEEP surgery. 6) Willing to retain cervical structure and/or function, voluntarily participating and signing an informed consent form.

Exclusion criteria

Exclusion criteria: 1) Preoperative cytological examination suspected the presence of cancerous lesions and infiltration; 2) Preoperative colposcopy examination showed lesions extending to the vaginal fornix and presence of vaginal wall lesions 3) Preoperative cervical pathology with cervical microfocal infiltration 4) Cervical LEEP surgery indicates cervical invasive cancer. 5) Severe pelvic inflammation, cervical inflammation, or other severe gynecological inflammation were found one week after cervical LEEP surgery 6) Individuals with undiagnosed vaginal bleeding; 7) Individuals currently suffering from allergic diseases; Suspected or known to have porphyria, or known to have a history of allergies to experimental drugs and drugs with similar chemical structures; 8) Individuals with severe cardiovascular, neurological, psychiatric, endocrine, liver function, and hematopoietic system diseases; Those who are known to have severe immune dysfunction or require long-term use of glucocorticoids and immunosuppressants; Patients with other malignant tumors; 9) Pregnant and lactating women; 10) Poor compliance, or expected inability to complete the trial and follow-up due to limitations such as place of residence; 11) In addition to the above, the researchers have determined that it is not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
Cervical biopsy pathology;HPV;Cervical cytology;

Countries

China

Contacts

Public ContactYi Chen

The International Peace Maternity & Child Health Hospital attached to Medicine College Shanghai Jiaotong University

yiyi_yuyu@126.com+86 186 2119 1967

Outcome results

None listed

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