Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Hysteroscopic Resection and Hormonal Therapy.
- Кому может быть актуально
- Состояния в реестре: Endometrial Adenocarcinoma, Endometrial Hyperplasia, Fertility Preservation, Conservative Treatment Therapy. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Италия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment
Обзор
This observational study aims to evaluate the obstetric and oncological outcomes of patients diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Eligible patients include women who received hysteroscopic surgery and hormonal therapy either to preserve fertility or due to medical contraindications to standard radical surgery. Follow-up lasts 12 months.
Подробное описание
This is a monocentric cohort study conducted at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. It includes women diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment using standardized hysteroscopic techniques performed by a single surgeon. The intervention consists of hysteroscopic lesion resection, insertion of a 52 mg levonorgestrel-releasing IUD, and in selected cases oral progestin therapy with Megestrol Acetate. The study includes both women desiring fertility preservation and patients medically unfit for radical surgery. Follow-up includes hysteroscopic biopsies at 3, 6, and 12 months. The primary objective is to assess obstetric outcomes, with secondary endpoints including oncologic outcomes.
Вмешательства
- Процедура Hysteroscopic Resection and Hormonal Therapy
Patients underwent hysteroscopic resection of atypical endometrial hyperplasia (AEH) or grade 1-2 endometrial adenocarcinoma (EAC) using a 15 Fr mini-resectoscope. Depending on the case, the procedure included visual D\&C or a combined technique. At the end of the procedure, a 52 mg levonorgestrel-releasing intrauterine device (LNG-IUD) was inserted. In patients with EAC G2 or poor prognostic markers (e.g., MMR deficiency), oral progestin therapy with Megestrol Acetate (160 mg daily) was added.
Первичные конечные точки
- Pregnancy Rate [Срок оценки: Within 12 months from histologically confirmed complete response]
- Miscarriage Rate [Срок оценки: Within 12 months from histologically confirmed complete response]
- Live Birth Rate [Срок оценки: Within 12 months from histologically confirmed complete response]
Вторичные конечные точки (1)
- Disease-Free Interval [Срок оценки: Up to 12 months after treatment]
Критерии участия
Критерии включения
- Female patients aged 18 years or older.
- Histological diagnosis of endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH).
- Patients who underwent conservative treatment with hysteroscopic resection at the CLASS Hysteroscopy Center, performed by a single experienced surgeon (U.C.).
- Patients treated conservatively due to medical contraindications to radical surgery (e.g., severe comorbidities).
- Signed informed consent for participation in the study.
Критерии исключения
- Patients with other known causes of infertility.
- Patients with non-endometrioid histological subtypes of endometrial adenocarcinoma.
- Patients under 18 years of age.
- Patients who did not provide informed consent for participation.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Италия · 1 центр
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma
Публикации
- Catena U, Mirandola M, Capomacchia FM, Fanfani F, Scambia G. A new surgical approach for fertility-sparing management of diffuse endometrial G2 endometrioid adenocarcinoma: a step-by-step technique. Facts Views Vis Obgyn. 2023 Mar;15(1):79-81. doi: 10.52054/FVVO.15.1.058. PMID 37010338
- Morice P, Leary A, Creutzberg C, Abu-Rustum N, Darai E. Endometrial cancer. Lancet. 2016 Mar 12;387(10023):1094-1108. doi: 10.1016/S0140-6736(15)00130-0. Epub 2015 Sep 6. PMID 26354523
- Jeon YT, Park IA, Kim YB, Kim JW, Park NH, Kang SB, Lee HP, Song YS. Steroid receptor expressions in endometrial cancer: clinical significance and epidemiological implication. Cancer Lett. 2006 Aug 8;239(2):198-204. doi: 10.1016/j.canlet.2005.08.001. Epub 2005 Sep 15. PMID 16168561
- Di Spiezio Sardo A, De Angelis MC, Della Corte L, Carugno J, Zizolfi B, Guadagno E, Gencarelli A, Cecchi E, Simoncini T, Bifulco G, Zullo F, Insabato L. Should endometrial biopsy under direct hysteroscopic visualization using the grasp technique become the new gold standard for the preoperative evaluation of the patient with endometrial cancer? Gynecol Oncol. 2020 Aug;158(2):347-353. doi: 10.1016/ PMID 32467056
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
Идентификаторы
NCT: NCT07077876 · 7309