A single-center, single-group exploratory study to investigate whether one-time administration of mixture of RI colloid and dye is as tolerable as standard separate administration of the two drugs for sentinel lymph node navigation in gastric cancer surgery

Matsumoto Yasunori0 个研究点目标入组 10 人开始时间: 2023年7月18日最近更新: 2023年10月17日

适应症

试验速览

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•1) Twenty years or older and Performance status (PS) of 0 or 1 according to ECOG criteria at the time of enrollment
•2) Patients with early gastric cancer diagnosed as cT1N0M0 by preoperative imaging exam and are indicated for surgical resection
•3) Solitary lesion with a long axis of 4 cm or less on diagnostic imaging
•4) Histological classification of biopsy samples indicate general types of gastric adenocarcinoma
•5) Written format of informed consent to participate in this research has been obtained from the patient

•1) History of allergy to the drug (99mtin colloid and indocyanine green)
•2) Lesion reaches cardiac orifice or pyloric ring
•3) Multiple lesions
•4) History of endoscopic treatment for the same lesion
•5) Residual gastric cancer after gastrectomy
•6) Lesion with absolute indication for endoscopic submucosal dissection (ESD)
•7) Patient with mental disorders such as dementia who require consent from legal reprisentatives
•8) In case of physicians assessment of possibilities not to conduct the study safely on the patient

发起方

Matsumoto Yasunori