Clinical trial NCT04615806: The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy
Official title: The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Indocyanine Green
Keywords: Esophageal Cancer
Indocyanine Green
the lymph node markers
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Accuracy rate of lymph node dissection
timeFrame: 1 week after operation
measure: False positive rate of lymph node dissection
timeFrame: 1 week after operation
measure: False negative rate of lymph node dissection
timeFrame: 1 week after operation
measure: Sensitivity and specificity of lymph node dissection
timeFrame: 1 week after operation
Secondary outcomes:
measure: The mapping of sentinel lymph nodes in esophageal cancer
timeFrame: 1 week after operation
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chun Chen, MD
role: STUDY_DIRECTOR
References:
citation: 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.