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Peer-reviewedCC BY 4.0Infection

Topical trichloroacetic acid versus electrocautery for treatment of anal intraepithelial neoplasia in people living with HIV: a multicentre, randomised, non-inferiority trial (TECAIN-study)

  • Stefan Esser1,2
  • Alexander Kreuter3
  • Anja Potthoff4
  • Robert Jablonka1,2,5
  • Mark Oette6
  • Martin F. Sprinzl7
  • Daniel Exner8,9
  • Konstantinos Bilbilis10
  • Hildegard Lax11
  • Eva-Maria Huessler11
  • Steffi Silling12
  • Ulrike Wieland12
12 affiliations
  1. 1Department of Dermatology and Venereology, Clinic for Dermatology and Venerology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45122 Essen, Germany
  2. 2HPSTD (HIV/AIDS, Proctology, STD) Outpatient Clinic, University Hospital Essen, University Duisburg-Essen, Essen, Germany
  3. 3Department of Dermatology, Venereology and Allergology, Helios St. Elisabeth Hospital, University Witten/Herdecke, Oberhausen, Germany
  4. 4WIR – Walk In RuhrInterdisciplinary Immunological Outpatient Clinic, Center for Sexual Health and Medicine, Department of Dermatology, Venereology and Allergology, Ruhr University Bochum, Bochum, Germany
  5. 5Present Address: Derma Center, Rietkötter & Jablonka, Gelsenkirchen, Germany
  6. 6Department of Infectious Diseases, Augustinerinnen Hospital, Cologne, Germany
  7. 7Department of Internal Medicine I, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
  8. 8Department of General, Visceral, Thoracic and Vascular Surgery, Colorectal Surgery and Proctology, University Hospital Bonn, Bonn, Germany
  9. 9Present Address: Department of General, Visceral and Coloproctological Surgery, Evangelical Amalie Sieveking Hospital, Hamburg, Germany
  10. 10Centre for Clinical Studies Essen, c/o IMIBE, University Hospital Essen, Essen, Germany
  11. 11Institute for Medical Informatics, Biometry and Epidemiology (IMIBE), University Hospital Essen, Essen, Germany
  12. 12Institute of Virology, National Reference Centre for Papilloma-and Polyomaviruses, Faculty of Medicine, University of Cologne, University Hospital Cologne, Cologne, Germany
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Abstract

Purpose: To compare efficacy and safety of topical trichloroacetic acid (TCA) versus electrocautery (ECA) for the treatment of human papillomavirus (HPV)-associated anal intraepithelial neoplasia (AIN) in people living with HIV (PLWH).

Methods: The TECAIN-study was a prospective, multicentre, randomised (1:1 block-randomisation), open-label, non-inferiority trial in PLWH with histologically confirmed AIN recruited from seven German proctological units. The primary endpoint (PE) was therapeutic success defined as a combination of complete clinical response evaluated by high-resolution-anoscopy and histological AIN-clearance/regression four weeks after the end-of-treatment (4-weeks-follow-up, 4WFU). Secondary endpoints were assessed at 4WFU and 24WFU. Efficacy was analysed in the intention-to-treat-population as primary analysis with a non-inferiority margin of -12%.

Results: Of 659 PLWH screened with HRA, 257 patients with AIN were randomised. Therapeutic outcome was assessed in 233 PLWH (TCA n = 118, ECA n = 115). The PE was reached in 62 patients of the TCA-group (52.5%) versus 71 patients of the ECA-group (61.7%) (difference in proportion − 9.2%, 95%CI -21.8% to 3.5%). While non-inferiority of TCA could not be shown for the PE at 4WFU, TCA was non-inferior to ECA at 24WFU (therapeutic success 50.8% vs. 48.7% (difference 2.2%, 95%CI -10.7% to 15.0%)). Adverse events occurred in 67.8% in both groups at 4WFU (mostly mild or moderate). Severe treatment-related pain was significantly less frequent in the TCA-group (4.2%) compared to the ECA-group (14.8%). HPV-findings did not differ between treatment groups between baseline and follow-up visits.

Conclusion: TCA is an effective, well-tolerated and less complex alternative to ECA for the treatment of AIN in PLWH.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s15010-026-02882-z.

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Cite

BibTeXRIS
BibTeX
@article{esser2026topical,
  title = {{Topical trichloroacetic acid versus electrocautery for treatment of anal intraepithelial neoplasia in people living with HIV: a multicentre, randomised, non-inferiority trial (TECAIN-study)}},
  author = {Stefan Esser and Alexander Kreuter and Anja Potthoff and Robert Jablonka and Mark Oette and Martin F. Sprinzl and Daniel Exner and Konstantinos Bilbilis and Hildegard Lax and Eva-Maria Huessler and Steffi Silling and Ulrike Wieland},
  journal = {Infection},
  year = {2026},
  month = jul,
  doi = {10.1007/s15010-026-02882-z},
  url = {https://doi.org/10.1007/s15010-026-02882-z},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Topical trichloroacetic acid versus electrocautery for treatment of anal intraepithelial neoplasia in people living with HIV: a multicentre, randomised, non-inferiority trial (TECAIN-study)
AU  - Stefan Esser
AU  - Alexander Kreuter
AU  - Anja Potthoff
AU  - Robert Jablonka
AU  - Mark Oette
AU  - Martin F. Sprinzl
AU  - Daniel Exner
AU  - Konstantinos Bilbilis
AU  - Hildegard Lax
AU  - Eva-Maria Huessler
AU  - Steffi Silling
AU  - Ulrike Wieland
PY  - 2026
DA  - 2026/07/10
JO  - Infection
DO  - 10.1007/s15010-026-02882-z
UR  - https://doi.org/10.1007/s15010-026-02882-z
AB  - Purpose: To compare efficacy and safety of topical trichloroacetic acid (TCA) versus electrocautery (ECA) for the treatment of human papillomavirus (HPV)-associated anal intraepithelial neoplasia (AIN) in people living with HIV (PLWH).  Methods: The TECAIN-study was a prospective, multicentre, randomised (1:1 block-randomisation), open-label, non-inferiority trial in PLWH with histologically confirmed AIN recruited from seven German proctological units. The primary endpoint (PE) was therapeutic success defined as a combination of complete clinical response evaluated by high-resolution-anoscopy and histological AIN-clearance/regression four weeks after the end-of-treatment (4-weeks-follow-up, 4WFU). Secondary endpoints were assessed at 4WFU and 24WFU. Efficacy was analysed in the intention-to-treat-population as primary analysis with a non-inferiority margin of -12%.  Results: Of 659 PLWH screened with HRA, 257 patients with AIN were randomised. Therapeutic outcome was assessed in 233 PLWH (TCA n = 118, ECA n = 115). The PE was reached in 62 patients of the TCA-group (52.5%) versus 71 patients of the ECA-group (61.7%) (difference in proportion − 9.2%, 95%CI -21.8% to 3.5%). While non-inferiority of TCA could not be shown for the PE at 4WFU, TCA was non-inferior to ECA at 24WFU (therapeutic success 50.8% vs. 48.7% (difference 2.2%, 95%CI -10.7% to 15.0%)). Adverse events occurred in 67.8% in both groups at 4WFU (mostly mild or moderate). Severe treatment-related pain was significantly less frequent in the TCA-group (4.2%) compared to the ECA-group (14.8%). HPV-findings did not differ between treatment groups between baseline and follow-up visits.  Conclusion: TCA is an effective, well-tolerated and less complex alternative to ECA for the treatment of AIN in PLWH.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s15010-026-02882-z.
SN  - 0300-8126
SN  - 1439-0973
ER  -