Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer
Overview
- Phase
- Phase 2
- Intervention
- Indocyanine Green Tracer
- Conditions
- Stomach Neoplasms
- Sponsor
- Fujian Medical University
- Enrollment
- 266
- Locations
- 1
- Primary Endpoint
- Total Number of Retrieved Lymph Nodes
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Chang-Ming Huang, Prof.
Clinical Professor
Fujian Medical University Union Hospital
Eligibility Criteria
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
Arms & Interventions
Indocyanine Green Tracer
Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Intervention: Indocyanine Green Tracer
No Indocyanine Green Tracer
Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Intervention: Indocyanine Green Tracer
Outcomes
Primary Outcomes
Total Number of Retrieved Lymph Nodes
Time Frame: 14 days
Compare total number of retrieved lymph nodes in both group.
Secondary Outcomes
- False positive rate(14 days)
- Negative rate(14 days)
- False negative rate(14 days)
- Number of Metastasis Lymph Nodes(14 days)
- Metastasis rate of lymph node(14 days)
- Morbidity and mortality rates(30 days)
- 3-year disease free survival rate(36 months)
- 3-year recurrence pattern(36 months)
- Incision length(1 day)
- The results of endoscopy(3, 6, 9 and 12 months)
- The variation of body temperature(8 days)
- The rate of fluorescence(14 days)
- Positive rate(14 days)
- The variation of cholesterol(3, 6, 9 and 12 months)
- The variation of album(3, 6, 9 and 12 months)
- 5-year recurrence pattern(60 months)
- Postoperative recovery course(10 days)
- Operation time(1 day)
- The variation of weight(3, 6, 9 and 12 months)
- Intraoperative blood loss(1 day)
- Conversive rate(1 day)
- Intraoperative morbidity rates(1 day)
- The variation of white blood cell count(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The variation of hemoglobin(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The variation of C-reactive protein(Preoperative 3 days and postoperative 1, 3, and 5 days)
- The variation of prealbumin(Preoperative 3 days and postoperative 1, 3, and 5 days)
- 3-year overall survival rate(36 months)
- 5-year overall survival rate(60 months)
- 5-year disease free survival rate(60 months)