A Phase 2 interventional study of Indocyanine Green Tracer in Gastric Cancer, sponsored by Fujian Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-11-16.
Sponsored by Fujian Medical University · Phase 2, Interventional, and Treatment
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer 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 remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 68 is close to the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
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(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent
Exclusion Criteria:
Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)
Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Total Number of Retrieved Lymph Nodes
Total Number of Retrieved Lymph Nodes
Time frame: 30 days
Lymph node noncompliance rate
Lymph node noncompliance rate
Time frame: 30 days
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group
Time frame: 30 days
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)
Time frame: 30 days
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)
Time frame: 30 days
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)
Time frame: 30 days
Number of Metastasis Lymph Nodes
Number of Metastasis Lymph Nodes
Time frame: 30 days
Metastasis rate of lymph node
Metastasis rate of lymph node
Time frame: 30 days
Postoperative morbidity rate
Postoperative morbidity rate
Time frame: 30 days
Postoperative mortality rate
Postoperative mortality rate
Time frame: 30 days
3-year overall survival rate
3-year overall survival rate
Time frame: 3 years
3-year disease-free survival rate
3-year disease-free survival rate
Time frame: 3 years
3-year recurrence pattern
3-year recurrence pattern
Time frame: 3 years
Postoperative recovery course
Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
Time frame: 30 days
Intraoperative situation
Operation time, intraoperative blood loss, and intraoperative morbidity rate
Time frame: 30 days
Plan to share: Undecided
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