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Intracavitary radiotherapy versus CO2 laser ablation for the treatment of high-grade squamous intraepithelial of vaginal stump (VAIN HSIL): a randomized, controlled, phase II trial

Intracavitary radiotherapy versus CO2 laser ablation for the treatment of high-grade squamous intraepithelial of vaginal stump (VAIN HSIL): a randomized, controlled, phase II trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096466
Enrollment
Unknown
Registered
2025-01-24
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

High-grade squamous intraepithelial of vaginal stump after total hysterectomy

Interventions

Radiotherapy treatment group:Radiotherapy treatment
CO2 laser treatment group:CO2 laser treatment

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily enrolled, good compliance, able to cooperate with the trial observation, and sign a written informed consent form; 2. Confirmed diagnosis of VAIN HSIL by tissue biopsy; 3. The age of the subjects was postmenopausal to 75 years old, and the KPS score of physical condition was >=70 points; 4. The expected survival of the subject is greater than 6 months; 5. Good cardiopulmonary, liver and kidney function, no contraindications to radiotherapy or CO2 laser therapy.

Exclusion criteria

Exclusion criteria: 1. Patients with poor general condition and severe heart, liver, kidney and hematological diseases that cannot tolerate radiotherapy or CO2 laser therapy; 2. Risk of invasive cancer; 3. Patients with poor compliance and lack of follow-up conditions; 4. Patients with a history of allergy to iodine contrast media, allergic constitution or in an allergic state; 5. Those who have been diagnosed with other malignant tumors in the past; 6. Those who refuse to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Treatment efficacy rate;

Countries

China

Contacts

Public ContactXiaowen Pu/Jing Yang

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

puxiaowen@51mch.com+86 13564941413

Outcome results

None listed

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