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.
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 31, 2014
- Procedure: Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy
- 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
Arms, Groups and Cohorts
- Experimental: NIR with ICG group
Clinical Trial Outcome Measures
- To compare the number of retrieved lymph node in each nodal station after additional application of near infra-red fluorescence imaging
- Time Frame: About 7 days after operation when pathologic result was reported
Participating in This Clinical Trial
1. Males or Females, aged≥20 years and ≤80 years 2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry 3. American Society of Anesthesiolosists (ASA) score of 1 to 3 4. Histologically confirmed adenocarcinoma in stomach 5. 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:
1. M1 status 2. Experience of previous gastric resection 3. Complication due to gastric cancer, such as complete obstruction or perforation 4. History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer 5. History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Yonsei University
- Provider of Information About this Clinical Study
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