Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Henan Cancer Hospital | OTHER_GOV |
| The First Affiliated Hospital of Xiamen University | OTHER |
| The University of Hong Kong | OTHER |
Not provided
Not provided
Not provided
Not provided
Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging in tracing sentinel lymph node during esophageal squamous cell carcinoma (ESCC) surgery, compared with the gold standard of complete lymph node dissection (CLND), in detecting metastatic disease. This study aims to address the following core questions:
Participants will:
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object. The investigators will divide participants into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.The investigators 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (ICG group) receiving VATS with near-infrared imaging with indocyanine green to visualize | Experimental |
| |
| (Control group) receiving VATS without near-infrared imaging with indocyanine g | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node | Drug | A multicenter, prospective cohort study will be conducted. Enrolled patients with esophageal squamous cell carcinoma will undergo minimally invasive radical esophagectomy. During surgery, ICG will be injected around the tumor under gastroscopy guidance, and fluorescent lymph nodes will be tracked using a thoracoscopic near-infrared camera. These lymph nodes will be grouped and marked by professional thoracic surgeons, and intraoperative frozen pathology results will be recorded. Subsequent CLND will be performed. The study will collect and analyze patients' clinical information, ICG imaging results, and pathological examination results to explore the effectiveness of the ICG imaging system. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy rate of lymph node dissection | According to postoperative pathological results, investigate the detection rate of metastatic lymph nodes using the near-infrared indocyanine green fluorescence imaging system in lymph node dissection for esophageal squamous cell carcinoma | 1 week after operation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The number of lymph nodes |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bin Zheng, M.D. | Contact | 15959002753 | lacustrian@163.com | |
| Jianting Du, M.D., Ph.D | Contact | 13023806690 | dujt1220@fjmu.edu.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujian Medical University Union Hospital | Fuzhou | Fujian | 350000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The number of lymph nodes between the both groups
| 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 |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019060 | Minimally Invasive Surgical Procedures |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided