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JRCT ID: jRCTs031230237

Registered date:18/07/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedGastric cancer
Date of first enrollment18/07/2023
Target sample size10
Countries of recruitment
Study typeInterventional
Intervention(s)day before surgery Indocyanine green-added 99m technetium-tin colloid will be administered, and SPECT/CT will be conducted to examine whether accumulation in regional lymph nodes can be visualized. during surgery At the beginning of surgery, RI-accumulating lymph nodes are surveyed using navigator GPS and dye-accumulating lymph nodes are surveyed using near-infrared fluorescence laparoscope. Postoperative The RI-accumulating lymph nodes and dye-accumulating lymph nodes are removed from the resected specimen, submitted for rapid pathological diagnosis, and the presence or absence of metastasis is investigated. The rest of the specimens are subjected to routine histopathological examination to check for metastases. Observation Observe for the presence or absence of adverse events.


Primary OutcomeNumber and rate of occurrence of adverse events related to the administrated drug from the date of administration to 1 month after surgery (day of first visit for follow-up after discharge)
Secondary Outcome1) Tolerability of endoscopic administration of the test drug using a endoscopic puncture needle. 2) The visualization rate and number of RI-accumulated lymph nodes by SPECT/CT one hour after the administration. 3) The identification rate and number of RI- and dye-accumulated lymph nodes identified during surgery, and the rate of concordance between RI- and dye-accumulated lymph nodes. 4) Identification rate and number of sentinel lymph nodes (RI- and/ordye-accumulated lymph nodes) identified during surgery. 5) Consistency of the sentinel-lymph-node theory in the metastatic status between the sentinel lymph node and the other regional lymph nodes 6) Total number of lymph nodes dissected by the surgery (number of sentinel lymph nodes + number of other regional lymph nodes).

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
Include criteria1) 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
Exclude criteria1) 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

Related Information


Public contact
Name Hideki Hayashi
Address 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
Affiliation Chiba University Hospital
Scientific contact
Name Yasunori Matsumoto
Address 1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba, Japan Chiba Japan 260-8677
Telephone +81-43-222-7171
Affiliation Chiba University Hospital