Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Study Overview
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Brief Summary
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Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or Females, aged≥20 years and ≤80 years Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry American Society of Anesthesiolosists (ASA) score of 1 to 3 Histologically confirmed adenocarcinoma in stomach Clinical stage I (T1N0M0, T2N0M0, T1N1M0) 5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study Exclusion Criteria: M1 status Experience of previous gastric resection Complication due to gastric cancer, such as complete obstruction or perforation History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NIR with ICG group<br> | Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy<br>* 0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging |  | About 7 days after operation when pathologic result was reported | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrectomy, near infrared, fluorescence imaging, indocyanine green