A Phase 3 interventional study of Subserosa injection of indocyanine green and submucosal injection of indocyanine green in Indocyanine Green, Gastric Cancer and Injection Site, sponsored by Fujian Medical University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-10.
Sponsored by Fujian Medical University · Phase 3, Interventional, and Treatment
The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied.
In recent years, with the successful application of ICG (indocyanine green) fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near-infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, which makes ICG fluorescence imaging guide laparoscopic radical resection of gastric cancer lymph node dissection has become a new exploration direction. ICG near-infrared imaging technology has important research value, good application prospects, and broad development space in laparoscopic radical resection of gastric cancer. However, at present, the application of ICG near-infrared imaging technology in laparoscopic radical resection of gastric cancer is still in the exploratory stage, and there is no unified standard. Therefore, in the world, there is still a lack of high-level evidence-based evidence of large-sample prospective randomized controlled trials to evaluate the effectiveness, safety, and feasibility of submucosal or subserous injection of ICG in guiding laparoscopic D2 resection of gastric cancer. The investigator first carried out this study in the world to evaluate the lymph node dissection and perioperative safety of gastric cancer patients who received a submucosal injection of ICG and subserous injection of ICG during laparoscopic radical gastrectomy in the same period, to promote the standardized development of ICG near-infrared imaging in laparoscopic radical gastrectomy.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 266 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Fujian Medical University is the lead sponsor of 144 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Subserosal injection of indocyanine green, with a concentration of 0.5 mg /ml, 6 points along the lesser and greater curvature of the stomach, 1.5 ml for each point.
Drug: Subserosa injection of indocyanine green
Submucosal injection of indocyanine green, with a concentration of 1.25mg /ml, four points around the primary tumor, each point 0.5 ml.
Drug: submucosal injection of indocyanine green
After preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.
Also known as: No other intervention
One day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.
Also known as: No other intervention
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
Time frame: One month after surgery
Total number of fluorescent lymph nodes in groups A and B
Total number of fluorescent lymph nodes in groups A and B
Time frame: One month after surgery
Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)
Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)
Time frame: One month after surgery
Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
Time frame: One month after surgery
Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
Time frame: One month after surgery
Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
Time frame: One month after surgery
Number of Metastasis Lymph Nodes
Number of Metastasis Lymph Nodes
Time frame: One month after surgery
Metastasis rate of lymph node
Metastasis rate of lymph node
Time frame: One month after surgery
Mortality rates
This is for the early mortality, which defined as the event observed within 30 days after surgery.
Time frame: 30 days
Morbidity rates
This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.
Time frame: 30 days
3-year disease free survival rate
Disease-free survival is calculated from the day of surgery to the day of recurrence or death (When the specific date of recurrence of the tumor is unknown, the endpoint is the date of death due to tumor causes). If neither death nor recurrence of the tumor is observed, the endpoint is the final date that a patient is confirmed as relapse-free. (The final date of DFS: The last date of the outpatient visit day or the date of acceptance of the examination).
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
Time to first ambulation
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 30 days
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
The variation of BMI in kg/m^2
The variation of BMI in kg/m\^2 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 morbidity rates
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 1 day
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
Lymph node noncompliance rate
Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.
Time frame: 1 day
Modified EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT14)
Participants were asked to complete one modified European Organisation for Research and Treatment of Cancer (EORTC) IN-PATSAT14 questionnaire before their discharge from hospital.
Time frame: 30 days
The Surgery Task Load Index (SURG-TLX)
Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
Time frame: 1 day
3-year overall survival rate
The overall survival is calculated from the day of surgery until death or until the final follow-up date, whichever occurs first. For survival cases, the endpoint is the last date that survival was confirmed. If the loss to follow-up occurred, the endpoint is the final date that survival could be confirmed.
Time frame: 36 months
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Fujian Medical University