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A trial of radiofrequency ablation for anal intraepithelial neoplasia

  • Original Article
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International Journal of Colorectal Disease Aims and scope Submit manuscript

Abstract

Purpose

Radiofrequency ablation (RFA) effectively treats esophageal high-grade dysplasia, but its efficacy in treating anal canal high-grade squamous intraepithelial lesions (HSILs) is unsubstantiated. This prospective study assessed the safety and efficacy of applying hemi-circumferential RFA to anal canal HSIL.

Methods

Twenty-one HIV-negative participants with HSIL occupying ≤ half the anal canal circumference were treated with hemi-circumferential anal canal RFA. Participants were assessed every 3 months for 12 months with high-resolution anoscopy; recurrence in the treatment zone was re-treated with focal RFA.

Results

Twenty-one participants with a mean of 1.7 lesions (range 1–4) enrolled and completed the trial. Six (29 %) participants had recurrent HSIL within the treated hemi-circumference within 1 year. Four participants (19 %) had persistence of an index lesion at 3 months. One (2.9 %) index HSIL persisted again at 12 months. No participants had more than two RFA treatments. KM curve-predicted HSIL-free survival within the treatment zone at 1 year was 76 % (95 % CI 52–89 %). Comparing the first 7 and last 14 participants, the predicted 1-year HSIL-free survivals are 43 % (95 % CI 10–73 %) and 93 % (95 % CI 59–99 %), respectively (p = 0.008), suggesting a learning curve with the treating physician. Multivariable analysis showed decreased recurrence in the last 14 participants (HR 0.02; 95 % CI 0.001–0.63) while increasing BMI increased recurrence (HR 1.43, 95 % CI 1.01–2.01). No participants had device or procedure-related serious adverse events, anal stricture, or heavy bleeding.

Conclusions

Hemi-circumferential RFA yielded a high rate of anal HSIL eradication in HIV-negative patients at 1 year with minimal adverse events. Lesion persistence was probably related to incomplete initial ablation.

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Acknowledgments

The authors thank the patients who volunteered for the study and the site study personnel and pathologists at Quest Diagnostics and Enzo Clinical Laboratories for their assistance in interpreting histology.

Author/coauthor contributions

Author contributions include conception and study design (SEG, SRH, SD), study recruitment and data acquisition (SEG), study analysis and interpretation of the data (SEG, RNG, TMD, AvZ), drafting of the article (SEG, RNG), critical revision of the article for important intellectual content (SEG, RNG, SRH, SD, TMD, AvZ), and final approval of the article (SEG, RNG, SRH, SD, TMD, AvZ).

Author information

Authors and Affiliations

  1. Massachusetts General Hospital, Boston, MA, USA

    Robert N. Goldstone

  2. Medtronic, Sunnyvale, CA, USA

    Shirin R. Hasan

  3. Medtronic, New Haven, CT, USA

    Steven Drury

  4. Departments of Pathology and Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA

    Teresa M. Darragh

  5. Department of Pathology, University of California San Francisco, San Francisco, CA, USA

    Annemieke van Zante

  6. Icahn School of Medicine, Mount Sinai, 420 West 23rd St, New York, NY, 10011, USA

    Stephen E. Goldstone

Authors
  1. Robert N. Goldstone
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  2. Shirin R. Hasan
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  3. Steven Drury
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  4. Teresa M. Darragh
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  5. Annemieke van Zante
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  6. Stephen E. Goldstone
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Corresponding author

Correspondence to Stephen E. Goldstone.

Ethics declarations

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

Conflict of interest

The study was sponsored and funded by Medtronic (Sunnyvale, CA). Medtronic provided medical writing assistance and statistical analysis support. SEG and TMD (or their institutions) received research support from Medtronic to conduct this trial. TMD has received supplies from Hologic. SRH and SD are employees and stockholders of Medtronic. SEG received consulting fees from Medtronic.

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Goldstone, R.N., Hasan, S.R., Drury, S. et al. A trial of radiofrequency ablation for anal intraepithelial neoplasia. Int J Colorectal Dis 32, 357–365 (2017). https://doi.org/10.1007/s00384-016-2679-2

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  • DOI: https://doi.org/10.1007/s00384-016-2679-2

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