Department of Gastric Surgery
Fuzhou, Fujian, China
NCT Number: NCT04973475
This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
Fuzhou, Fujian, China
After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer
Other names: ICG
Time frame: One month after surgery
The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Time frame: One month after surgery
The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Time frame: One month after surgery
The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes
Time frame: One month after surgery
The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes
Time frame: One month after surgery
Total number of retrieved lymph nodes
Time frame: One month after surgery
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: One month after surgery
Number of Metastasis Lymph Nodes
Time frame: One month after surgery
Metastasis rate of lymph node
Time frame: One month after surgery
This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
3-year disease free survival rate
Time frame: 36 months
Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
Time frame: 1 day
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
Time frame: 30 days
Time to first ambulation in hours is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
Time frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
Time frame: 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.
Time frame: 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.
Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
Contact information is provided by the study sponsor or research team.
Chang-Ming Huang, MD
CONTACT
Zu-Kai Wang, MD
CONTACT
Fujian Medical University
Other
Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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