Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

Study Overview
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Brief Summary
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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）.

Detailed Description
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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.

Official Title
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Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer

Conditions
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Stomach Neoplasms, Indocyanine Green

Intervention / Treatment
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* Drug: Indocyanine Green Tracer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) American Society of Anesthesiology score (ASA) class I, II, or III Written informed consent Exclusion Criteria: Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except laparoscopic cholecystectomy) History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging History of other malignant disease within past five years History of previous neoadjuvant chemotherapy or radiotherapy History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement of simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1<50% of predicted values Diffuse; widespread; plastica

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine Green Tracer<br>Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group. | Drug: Indocyanine Green Tracer<br>* Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer<br>* Other names: ICG;|
| Active Comparator: No Indocyanine Green Tracer<br>Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group. | Drug: Indocyanine Green Tracer<br>* Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Retrieved Lymph Nodes | Compare total number of retrieved lymph nodes in both group. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 14 days | 
| Number of Metastasis Lymph Nodes | Compare number of positive lymph nodes in both group. | 14 days | 
| Metastasis rate of lymph node | Compare metastasis rate of lymph node in both group | 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. | 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 | 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. | 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. | 10 days | 
| Operation time |  | 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. | 3, 6, 9 and 12 months | 
| Intraoperative blood loss |  | 1 day | 
| Conversive rate |  | 1 day | 
| Intraoperative morbidity rates | The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. | 1 day | 
| Incision length |  | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Gastrectomy, Lymph Node Dissection