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J Gynecol Oncol. 2019 May;30(3):e42. English. Original Article. https://doi.org/10.3802/jgo.2019.30.e42
Kolben TM , Etzel LT , Bergauer F , Hagemann I , Hillemanns P , Repper M , Kaufmann AM , Sotlar K , Kolben T , Helms HJ , Gallwas J , Mahner S , Dannecker C .
Department of Obstetrics and Gynecology, University Hospital, LMU Munich, Munich, Germany. Theresa.Kolben@med.uni-muenchen.de
Amedes MVZ for Gynecology and Pathology Munich GmbH, Munich, Germany.
Dysplasie Einheit abts+partner, Kiel, Germany.
Department of Obstetrics and Gynaecology, Hannover Medical School, Hannover, Germany.
Department for Gynecology, Charité-Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin, Germany.
Institute of Pathology, University Hospital Salzburg, Paracelsus Medical University, Salzburg, Austria.
Department of Medical Statistics, University Medical Center Goettingen, Goettingen, Germany.
Abstract

Objective

To show noninferiority of a limited-excision (resection of the dysplastic lesion only) vs. classical Large Loop Excision of the Transformation Zone (LLETZ).

Methods

In this prospective, randomized, multicenter trial, women with human papillomavirus (HPV) positive cervical intraepithelial neoplasia grade 3 were randomized into two groups (1:1). Primary outcome was the rate of negative HPV tests after 6 months, secondary outcomes included cone size, complete resection rates as well as cytological and histological results after 6 and 12 months. A sample size of 1,000 was calculated to show noninferiority of the limited-excision compared to the LLETZ group using a noninferiority margin of 5%. Enrollment was stopped after 100 patients due to slow accrual.

Results

Patients in the limited-excision group did not show a lower number of negative HPV tests (78% [LLETZ]−80% [limited-excision]=−2%; 90% confidence interval=−15%, 12%). The limited-excision resulted in a substantially lower cone size (LLETZ: 1.97 mL vs. limited-excision: 1.02 mL; p < 0.001) but higher numbers of involved margins (LLETZ: 8% vs. limited-excision: 20%). Although postoperative cytological results slightly differed, histological results were similar in both groups. One limited-excision patient received immediate re-conisation, whereas one patient in each group was scheduled for re-conisation after 6 months.

Conclusion

The limited-excision could represent a promising option to reduce the surgical extent of conisations while maintaining oncological safety. The trial was not sufficiently powered to reach statistical significance due to early termination. Nevertheless, the study provides important insights in the feasibility of a limited-excision and could serve as a pilot study for future trials.

Trial Registration

German Clinical Trials Register Identifier: DRKS00006169

Copyright © 2019. Korean Association of Medical Journal Editors.