An interventional study of Indocyanine green solution in Esophageal Cancer and Indocyanine Green, sponsored by Fujian Medical University Union Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Fujian Medical University Union Hospital · Not applicable, Interventional, and Treatment
Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's planned enrollment of 40 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Fujian Medical University Union Hospital is the lead sponsor of 100 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml.
Drug: Indocyanine green solution
This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection.
ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.
Also known as: Indocyanine Green for Injection
Accuracy rate of lymph node dissection
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
Time frame: 1 week after operation
False positive rate of lymph node dissection
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
Time frame: 1 week after operation
False negative rate of lymph node dissection
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Time frame: 1 week after operation
Sensitivity and specificity of lymph node dissection
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
Time frame: 1 week after operation
The mapping of sentinel lymph nodes in esophageal cancer
The mapping of sentinel lymph nodes in esophageal cancer
Time frame: 1 week after operation
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Fujian Medical University Union Hospital