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

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

Conización cervical más linfadenectomía pélvica radical bilateral comomanejo conservador del cáncer de cérvix IB 1: reporte de un caso y revisión de la literatura / Cervical conisation plus radical bilateral pelvic lymph node dissection as conservative treatment for cervical cancer IB1: case report and review of the literature

Objetivo: describir el caso de una paciente con cáncer de cérvix en estadio FIGO IB1, a quien se le realizó conización cervical más linfadenectomía pélvica para preservar su fertilidad, y hacer una revisión de la literatura sobre sus indicaciones, efectividad y seguridad en términos de resultados oncológicos y obstétricos.Materiales y métodos: se presenta el caso de una paciente de 26 años, con diagnóstico de adenocarcinoma infiltrante de cérvix estadio IB1, atendida en la Clínica Julio Enrique Medrano de SaludCoop, Barranquilla (Colombia), institución de alto nivel de complejidad que atiende pacientes pertenecientes al régimen contributivo del sistema de seguridad social. Se realizó conización cervical más linfadenectomía pélvica, para preservar fertilidad. Al segundo año de seguimiento logró embarazo a término y 48 meses después se encuentra libre de enfermedad. Se realizó una búsqueda electrónica, sin restricción de idioma, de la literatura publicada hasta julio de 2015 con las palabras claves: Uterine Cervical Neoplasms, Fertility Preservation, Conization, Gynecologic Surgical Procedures y Lymph Node Excision, en las bases de datos Medline, Embase, CINAHL y Cochrane, y en las referencias bibliográficas de estudios recuperados.Resultados: se identificaron nueve artículos: ocho estudios de cohorte y un de reporte de caso. La conización cervical más linfadenectomía pélvica radical bilateral, es un procedimiento menos radical, seguro y efectivo para el manejo conservador del cáncer de cérvix de bajo riesgo. En pacientes sometidas a conización se reportan recidivas en un 2,84 %; 38 % logran embarazo, de los cuales el 70,2 % llegan a término.Conclusiones: la conización cervical más linfadenectomía pélvica radical bilateral podría ser una opción para el manejo de pacientes con cáncer de cérvix en estadios iniciales considerados de bajo riesgo que deseen conservar su fertilidad

Objective: To describe the case of a patient with cervical cancer FIGO stage IB1 taken to conisation and pelvic lymphadenectomy with the aim of preserving fertility, and to conduct a search in the literature regarding indications, effectiveness and safety of this procedure in terms of obstetric and oncologic outcomes.Materials and methods: We present the case of a 26-year old female patient seen at the Julio Enrique Medrano SaludCoop Clinic (Barranquilla, Colombia), a high-complexity institution that serves a population belonging to the contributory regime of the social security system. The patient was diagnosed with infiltrating cervical carcinoma stage IB1. She was taken to cervical cone biopsy plus pelvic lymph node dissection in order to preserve fertility. Two years into follow-up she achieved a term pregnancy, and 48 months later she is disease-free. An online search was conducted of the literature published until July 2015, with no language restriction, using the key words Uterine Cer vical Neoplasms, Fertilit y Preser vation, Conization, Gynaecologic Surgical Procedures and Lymph Node Excision in the Medline, Embase, CINAHL and Cochrane databases and in the bibliographic references of retrieved studies.Results: Overall, 9 articles were identified: 8 cohort studies and 1 case report. Cervical conisation plus bilateral radical pelvic lymphadenectomy is a less radical, safer and effective procedure for the conservative management of low-risk cervical cancer. A relapse rate of 2.84 % has been reported in patients subjected to conisation, pregnancy is achieved in 38 % of cases and, of those, 70.2 % come to term.Conclusions: Cervical conisation plus bilateral radical pelvic lymphadenectomy may be a management option for patients with low-risk, early-stage cervical cancer who wish to preserve their fertility