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

JRCT ID: jRCTs031230237

Registered date:18/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Gastric cancer
• Date of first enrollment: 18/07/2023
• Target sample size: 10
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Number 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 Outcome

1) 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 maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Matsumoto Yasunori
• Source(s) of Monetary Support: Clinical Research Initiation-Fund (of Chiba University Hospital)