Local Cecal Cancer - Optimization of Surgical 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: ileocecal resection with extended D3 lymphadenectomy., Right hemicolectomy with D3 lymphadenectomy..
- Кому может быть актуально
- Состояния в реестре: Colonic Neoplasms Malignant, Cecal Neoplasms. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Россия
- 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
Study of the Oncological Outcomes of Ileocecal Resection With D3 for Cecal Cancer
Обзор
The purpose of this study is to determine the clinical efficacy, safety, and oncologic outcomes of ileocecal resection (ICR) with D3 lymphadenectomy compared to standard right hemicolectomy(RHC) for cecal cancer.
Подробное описание
The design involves random allocation of eligible patients to ICR or RHC group in 1:1 ratio.
Requirements applied to centers participating in the trial and surgeons performing procedures are described in the protocol and refer to center volume and surgeon's experience.
Regular quality control includes the requirement to photograph the surgical specimen with a mark to determine the extent of lymphadenectomy performed and the number of the lymph node group.
After surgery patients are treated according to local standards, regardless of whether ICR or RHC was performed. Short-term and long-term outcomes are recorded according to the protocol.
Intervention. In all cases the tumor is localized in the area of the cecum; the border of the transition to the ascending colon is the upper lip of the ileocecal valve. The patient is not included in the study if the preoperative stage of examination reveals: synchronous cancer, distant metastasis (M1), locally advanced nature of the primary tumor (cT \> 3).
All patients will be randomly divided into two groups in a 1:1 ratio.
1. Research group (ICR) - Laparoscopy ileocecal resection with extended D3 lymphadenectomy (including 201, 202, 203 and 213 groups of lymph nodes). The minimum distance from the tumor is 10 cm, along the line of adequate blood supply. Next step - formation of a manual double-row ileo-ascendo-anastomosis. 2. Control group (RHC) - Laparoscopy right hemicolectomy with D3 lymphadenectomy (including 211, 212, 221, 222-rt groups of lymph nodes). Next step - formation of a manual double-row ileo-transverse-anastomosis.
Expected Results. The ICR will improve the short-term results of treatment of patients with cecal cancer compared with the standard RHC technique without affecting long-term results.
Вмешательства
- Процедура ileocecal resection with extended D3 lymphadenectomy.
Laparoscopy ileocecal resectionith extended D3 lymphadenectomy including 201, 202, 203 and 213 groups of lymph nodes. Manual double-row ileo-ascendo-anastomosis. - Процедура Right hemicolectomy with D3 lymphadenectomy.
Laparoscopy right hemicolectomy with D3 lymphadenectomy including 201, 202, 203, 213, 211, 212, 221, 222-rt groups of lymph nodes. Manual double-row ileo-transverse-anastomosis.
Первичные конечные точки
- Overall survival. [Срок оценки: 5 years after the last patient.]
- Disease-free survival. [Срок оценки: 3 years after the last patient.]
- Disease-free survival. [Срок оценки: 5 years after the last patient.]
Вторичные конечные точки (10)
- Postoperative morbidity. [Срок оценки: The first 30 days after surgery.]
- Postoperative mortality. [Срок оценки: The first 30 days after surgery.]
- Total number of lymph nodes removed. [Срок оценки: Post-intervention at week 3.]
- Total number of metastatic lymph nodes and correlation by group. [Срок оценки: Post-intervention at week 3.]
- Total length of removed bowel. [Срок оценки: Post-intervention at week 3.]
- Area of mesentery removed. [Срок оценки: Post-intervention at week 3.]
- Description of blood loss during the intraoperative period. [Срок оценки: During the surgery.]
- Operation time. [Срок оценки: Immediately after the surgery.]
- Conversion. [Срок оценки: During the surgery.]
- Number of days of inpatient treatment. [Срок оценки: During hospitalization up to 4 weeks]
Критерии участия
Критерии включения
- At least 18 years of age.
- ECOG status 0-2.
- Histologically confirmed adenocarcinoma of the colon.
- Clinical stage T1-3; N+; M0.
- The physical status from ASA classification I, II, III or IV.
- Written informed consent.
Критерии исключения
- Synchronous or metachronous malignancy.
- Locally-advanced tumor (T>3).
- Presence of distant metastases (M1).
- Complicated tumor: obstruction, perforation.
- Neoadjuvant chemotherapy.
- Medical contraindications for surgical treatment.
- Pregnancy or breast feeding.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent or comply with the study protocol.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Россия · 1 центр
- Moscow Clinical Scientific Center — Moscow
Идентификаторы
NCT: NCT06121089 · 10/2022