Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection
- Conditions
- Indocyanine GreenGastric CancerInjection Site
- Interventions
- Drug: submucosal injection of indocyanine greenDrug: Subserosa injection of indocyanine green
- Registration Number
- NCT04219332
- Lead Sponsor
- Fujian Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 266
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Submucosal injection of indocyanine green tracer group submucosal 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. Subserosal injection of indocyanine green tracer group Subserosa injection of indocyanine green 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.
- Primary Outcome Measures
Name Time Method Total Number of Retrieved Lymph Nodes One month after surgery Total Number of Retrieved Lymph Nodes
- Secondary Outcome Measures
Name Time Method Metastasis rate of lymph node One month after surgery Metastasis rate of lymph node
Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate) 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 negative lymph nodes in groups A and B (false positive rate) One month after surgery Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate) One month after surgery Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
Time to first ambulation 30 days Time to first ambulation in hours is used to assess the postoperative recovery course.
Time to first liquid diet 30 days Time to first liquid diet in days is used to assess the postoperative recovery course.
3-year disease free survival rate 36 months 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).
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.
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 morbidity rates 1 day The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
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 Surgery Task Load Index (SURG-TLX) 1 day Surgeons were required to complete one modified SURG-TLX questionnaire for each procedure.
3-year overall survival rate 36 months 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.
Total number of fluorescent lymph nodes in groups A and B One month after surgery Total number of fluorescent lymph nodes in groups A and B
Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate) One month after surgery Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
Number of Metastasis Lymph Nodes One month after surgery Number of Metastasis Lymph Nodes
Mortality rates 30 days This is for the early mortality, which defined as the event observed within 30 days after surgery.
Morbidity rates 30 days This is for the incidence of early postoperative complications, which defined as the event observed within 30 days after surgery.
Time to first flatus 30 days Time to first flatus in days is used to assess the postoperative recovery course.
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 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.
Modified EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT14) 30 days 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 to first soft diet 30 days Time to first soft diet in days is used to assess the postoperative recovery course.
Duration of postoperative hospital stay 30 days Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
The variation of BMI in kg/m^2 3, 6, 9 and 12 months 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.
Lymph node noncompliance rate 1 day 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.
Trial Locations
- Locations (1)
Department of Gastric Surgery
🇨🇳Fuzhou, Fujian, China