Esophageal Cancer, Indocyanine Green
Conditions
Keywords
Esophageal Cancer, Indocyanine Green, the lymph node markers
Brief summary
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.
Detailed description
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.
Interventions
ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.
Sponsors
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age and gender: 18-75 years old, male and female unlimited; 2. Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma; 3. Preoperative combination with neoadjuvant chemoradiotherapy; 4. Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis; 5. Heart, lung, liver and kidney functions can tolerate operation; 6. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.
Exclusion criteria
1. Allergic to ICG or iodine; 2. Patients with a history of chest surgery or thoracic lymph node dissection; 3. Patients needing emergency surgery; 4. Patients whose tumors involve neighboring organs and need to be removed by combining organs; 5. Patients with tumor recurrence or distant metastasis; 6. Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included; 7. A history of serious mental illness; 8. Pregnant or lactating women; 9. Patients with other conditions considered by the researcher should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy rate of lymph node dissection | 1 week after operation | Accuracy rate of lymph node dissection of each arm（according to postoperative pathology） |
| False positive rate of lymph node dissection | 1 week after operation | False positive rate of lymph node dissectionof each arm（according to postoperative pathology） |
| False negative rate of lymph node dissection | 1 week after operation | False negative rate of lymph node dissection of each arm（according to postoperative pathology） |
| Sensitivity and specificity of lymph node dissection | 1 week after operation | Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The mapping of sentinel lymph nodes in esophageal cancer | 1 week after operation | The mapping of sentinel lymph nodes in esophageal cancer |
Countries
China
Contacts
Primary ContactBin Zheng, MD
Outcome results
None listed