Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
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: Indocyanine Green Tracer.
- Кому может быть актуально
- Состояния в реестре: Gastric Cancer. Базовые параметры: 18 лет — 75 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
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
Подробное описание
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.
Вмешательства
- Препарат Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Первичные конечные точки
- Total Number of Retrieved Lymph Nodes [Срок оценки: 30 days]
Вторичные конечные точки (12)
- Lymph node noncompliance rate [Срок оценки: 30 days]
- Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group [Срок оценки: 30 days]
- Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate) [Срок оценки: 30 days]
- Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate) [Срок оценки: 30 days]
- Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate) [Срок оценки: 30 days]
- Number of Metastasis Lymph Nodes [Срок оценки: 30 days]
- Metastasis rate of lymph node [Срок оценки: 30 days]
- Postoperative morbidity rate [Срок оценки: 30 days]
- Postoperative mortality rate [Срок оценки: 30 days]
- 3-year overall survival rate [Срок оценки: 3 years]
- 3-year disease-free survival rate [Срок оценки: 3 years]
- 3-year recurrence pattern [Срок оценки: 3 years]
Критерии участия
Критерии включения
- Age from 18 to 75 years
- Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)
(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent
Критерии исключения
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
- History of allergy to iodine agents
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past six months
- History of unstable angina or myocardial infarction within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for another disease
- Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Linitis plastica, Widespread
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Fujian Medical University Union Hospital — Фучжоу
Идентификаторы
NCT: NCT05618821 · FUGES-027