The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.
Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma. On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
266
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Total Number of Retrieved Lymph Nodes
Compare total number of retrieved lymph nodes in both group.
Time frame: 14 days
The rate of fluorescence
The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Time frame: 14 days
Positive rate
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Time frame: 14 days
False positive rate
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Time frame: 14 days
Negative rate
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Time frame: 14 days
False negative rate
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
Time frame: 14 days
Number of Metastasis Lymph Nodes
Compare number of positive lymph nodes in both group.
Time frame: 14 days
Metastasis rate of lymph node
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Compare metastasis rate of lymph node in both group
Time frame: 14 days
Morbidity and mortality rates
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Time frame: 30 days
3-year disease free survival rate
disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Time frame: 36 months
3-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time frame: 36 months
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
Time frame: 10 days
Operation time
Time frame: 1 day
The variation of weight
The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time frame: 3, 6, 9 and 12 months
Intraoperative blood loss
Time frame: 1 day
Conversive rate
Time frame: 1 day
Intraoperative morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 1 day
Incision length
Time frame: 1 day
The variation of cholesterol
The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time frame: 3, 6, 9 and 12 months
The variation of album
The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Time frame: 3, 6, 9 and 12 months
The results of endoscopy
The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
Time frame: 3, 6, 9 and 12 months
The variation of body temperature
The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
Time frame: 8 days
The variation of white blood cell count
The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of hemoglobin
The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of prealbumin
The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
3-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Time frame: 36 months
5-year overall survival rate
Overall survival was defined as the time from surgery to death from any cause
Time frame: 60 months
5-year disease free survival rate
disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Time frame: 60 months
5-year recurrence pattern
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time frame: 60 months