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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIR-ICG | Experimental | 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. |
|
| Control | No Intervention | This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green solution | Drug | ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy rate of lymph node dissection | Accuracy rate of lymph node dissection of each arm(according to postoperative pathology) | 1 week after operation |
| False positive rate of lymph node dissection | False positive rate of lymph node dissectionof each arm(according to postoperative pathology) | 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) | 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) | 1 week after operation |
| Measure | Description | Time Frame |
|---|---|---|
| The mapping of sentinel lymph nodes in esophageal cancer | The mapping of sentinel lymph nodes in esophageal cancer | 1 week after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zheng, MD | Contact | 13023806690 | Dujt1220@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Chun Chen, MD | Fujian Medical University Union Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38012899 | Derived | Du J, Zeng T, Zhang S, Chen M, Huang G, Xu C, Xu G, Ni C, Hong R, Zheng W, Chen C, Zheng B. Comparison of indocyanine green-near-infrared fluorescence guided and traditional mediastinal lymphadenectomy during radical esophagectomy: A randomized controlled trial. Surgery. 2024 Feb;175(2):347-352. doi: 10.1016/j.surg.2023.10.007. Epub 2023 Nov 26. | |
| 35770339 |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| D007267 | Injections |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Du J, Xu G, Yang Z, Zheng B, Chen C. Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial. Thorac Cancer. 2022 Aug;13(15):2283-2287. doi: 10.1111/1759-7714.14548. Epub 2022 Jun 29. |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |