J Gynecol Oncol.  2019 May;30(3):e42. 10.3802/jgo.2019.30.e42.

A randomized trial comparing limited-excision conisation to Large Loop Excision of the Transformation Zone (LLETZ) in cervical dysplasia patients

• Kolben TM
• Etzel LT
• Bergauer F
• Hagemann I
• Hillemanns P
• Repper M
• Kaufmann A
• Sotlar K
• Kolben T
• Helms HJ
• Gallwas J
• Mahner S
• Dannecker

• KMID: 2440508
• DOI: http://doi.org/10.3802/jgo.2019.30.e42

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

Keyword

Cervical Intraepithelial Neoplasia; Conisation; Premature Birth

MeSH Terms

Cervical Intraepithelial Neoplasia
Conization*
Female
Humans
Multicenter Studies as Topic
Pilot Projects
Premature Birth
Prospective Studies
Sample Size