Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Location status: Recruiting
NCT Number: NCT05618821
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 2
Fuzhou, Fujian, 350000, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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 with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Time frame: 30 days
Total Number of Retrieved Lymph Nodes
Time frame: 30 days
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
Time frame: 30 days
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)
Time frame: 30 days
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
Time frame: 30 days
Metastasis rate of lymph node
Time frame: 30 days
Postoperative morbidity rate
Time frame: 30 days
Postoperative mortality rate
Time frame: 3 years
3-year overall survival rate
Time frame: 3 years
3-year disease-free survival rate
Time frame: 3 years
3-year recurrence pattern
Time frame: 30 days
Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
Time frame: 30 days
Operation time, intraoperative blood loss, and intraoperative morbidity rate
Contact information is provided by the study sponsor or research team.
Fujian Medical University
Other
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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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