臨床研究等提出・公開システム

Electrocautery ablation therapy for anal intraepithelial carcinoma

Anal carcinoma study

20

The median age at enrollment was 45 years, and all participants were men who have sex with men, with 90% being HIV-positive.

All 20 patients who underwent ablation therapy were subjected to follow-up biopsies at 3 and 6 months post-treatment a 100% retention rate with no loss to follow-up was achieved.

No reportable adverse events were identified.

Primary Outcome Local Cure Rate of Precancerous Lesions at 6 Months Cure rate at 6 months: 50% (10/20) Secondary Outcomes Overall Cure Rate of Precancerous Lesions at 6 Months Cure rate at 6 months: 40% (8/20) Cure Rate of Overall and Local Precancerous Lesions at 3 Months Overall cure rate at 3 months: 35% (7/20) Local cure rate at 3 months: 40% (8/20) Adverse Event Rate Post-Ablation Severe Adverse events: 0% (0/20)

This study assessed the efficacy and safety of electrocautery ablation for HSILs in men using high-resolution anoscopy (HRA). In this single-arm pilot study of 20 participants, local cure rates were 40% at 3 months and 50% at 6 months, while total cure rates were 35% and 40%. Ectopic recurrence occurred in 38.9%, and all adverse events were mild. Although the treatment was moderately effective, high recurrence rates highlight the need for further research with larger sample sizes and longer follow-up.

Dec. 17, 2024

Yes

If you are interested, please contact the principal investigator.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032210649

Ando Naokatsu

National Center for Global Health and Medicine

1-21-1 Toyama, Shinjuku-ku Tokyo Japan

nandou@hosp.ncgm.go.jp

Ando Naokatsu

National Center for Global Health and Medicine

1-21-1 Toyama, Shinjuku-ku Tokyo Japan

+81-332027181

nandou@hosp.ncgm.go.jp

Complete

Mar. 07, 2022

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Subjects who have given written consent to participate in the study.
2) person aged 20 years or older.
3) Patients with a diagnosis of anal intraepithelial carcinoma or neoplasia based on the results of histological findings

1) Invasive cancer
2) Patients whom the principal investigator judges to be inappropriate for inclusion in the study.
3) pregnant or breastfeeding woman

Both

Anal carcinoma

Electrocautery ablation therapy using Surgitron dual EMC for anal intraepithelial carcinoma

Ananl carcinoma, Human papillomavirus

ablation

D001005

D000078703

Eradication rate of anal carcinoma after 6 months

Eradication rate of anal carcinoma after 3 months
The rate of complication after ablation therapy

+81-3-3202-7181

Oct. 21, 2021

none