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Идёт набор NCT06945718

Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)

— Наблюдательное Gastric Cancer Surgery

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: beyond D2 regional lymph node dissection.
Кому может быть актуально
Состояния в реестре: Gastric Cancer, Surgery. 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
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Официальное название

Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)

Обзор

Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.

Вмешательства

  • Процедура beyond D2 regional lymph node dissection
    dissect the lymph nodes outside the extent of D2 LN region.

Первичные конечные точки

  • 3-year disease free survival rate [Срок оценки: 3 years]
Вторичные конечные точки (12)
  • Total number of retrieved lymph nodes [Срок оценки: 30 days]
  • Noncompliance rate of lymph node dissection [Срок оценки: 30 days]
  • Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A [Срок оценки: 30 days]
  • Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate) [Срок оценки: 30 days]
  • Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate) [Срок оценки: 30 days]
  • Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate) [Срок оценки: 30 days]
  • Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate) [Срок оценки: 30 days]
  • Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B [Срок оценки: 30 days]
  • Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate) [Срок оценки: 30 days]
  • Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate) [Срок оценки: 30 days]
  • Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate) [Срок оценки: 30 days]
  • Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate) [Срок оценки: 30 days]

Критерии участия

Критерии включения

Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent

Критерии исключения

Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in D3 region.

Other malignant disease within the past 5 years History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)<50% of predicted values Diffuse invasive gastric cancer Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy Patients who declined laparoscopic surgery

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Fujian Medical University Union Hospital — Фучжоу

Идентификаторы

NCT: NCT06945718 · FUGES-30

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗