Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection
- Conditions
- Stomach NeoplasmsIndocyanine Green
- Interventions
- Drug: Indocyanine Green Tracer
- Registration Number
- NCT03050879
- Lead Sponsor
- Fujian Medical University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 266
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Indocyanine Green Tracer Indocyanine Green Tracer Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group. No Indocyanine Green Tracer Indocyanine Green Tracer Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
- Primary Outcome Measures
Name Time Method Total Number of Retrieved Lymph Nodes 14 days Compare total number of retrieved lymph nodes in both group.
- Secondary Outcome Measures
Name Time Method False positive rate 14 days The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
Negative rate 14 days 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
False negative rate 14 days 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
Number of Metastasis Lymph Nodes 14 days Compare number of positive lymph nodes in both group.
Metastasis rate of lymph node 14 days Compare metastasis rate of lymph node in both group
Morbidity and mortality rates 30 days This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
3-year disease free survival rate 36 months disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
3-year recurrence pattern 36 months Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Incision length 1 day The results of endoscopy 3, 6, 9 and 12 months The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
The variation of body temperature 8 days The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
The rate of fluorescence 14 days The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
Positive rate 14 days The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
The variation of cholesterol 3, 6, 9 and 12 months 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.
The variation of album 3, 6, 9 and 12 months 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.
5-year recurrence pattern 60 months Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Postoperative recovery course 10 days 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.
Operation time 1 day The variation of weight 3, 6, 9 and 12 months The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
Intraoperative blood loss 1 day Conversive rate 1 day Intraoperative morbidity rates 1 day The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
The variation of white blood cell count Preoperative 3 days and postoperative 1, 3, and 5 days 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.
The variation of hemoglobin Preoperative 3 days and postoperative 1, 3, and 5 days 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.
The variation of C-reactive protein Preoperative 3 days and postoperative 1, 3, and 5 days 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.
The variation of prealbumin Preoperative 3 days and postoperative 1, 3, and 5 days 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.
3-year overall survival rate 36 months Overall survival was defined as the time from surgery to death from any cause
5-year overall survival rate 60 months Overall survival was defined as the time from surgery to death from any cause
5-year disease free survival rate 60 months disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause
Trial Locations
- Locations (1)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China