Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer
Status:
Recruiting
Trial end date:
2021-11-30
Target enrollment:
Participant gender:
Summary
The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China,
which become a severe challenge for public health. Esophagectomy is the preferred choice for
the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy
has improved patient survival and reduced tumor recurrence, Surgery-related complications
increased dramatically.
It has become a research hotspot to find an effective detection method to identify the lymph
node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging
technology has been developed for intra-operative visualization and precise resection of the
tumors.
Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared
imaging system for the surgical navigation technology, which has a relatively positive effect
in the clinical application of gastric cancer and liver cancer.There are few reports on the
application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This
study intends to identify the detection rate of sentinel lymph node (SLN) and determine the
accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique,
which provides clinical evidence for subsequent precise resection of the lymph nodes.
This will be one-arm prospective trial. The ESCC patients will be recruited with strict
criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. The
submucosal injection of ICG will be performed preoperatively by gastroscopy on the superior
and inferior edge of the esophageal tumor. NIR fluorescence imaging will be performed
intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN.
According to the standard procedure, 3 field lymphadenectomy will be performed, and all the
resected lymph nodes will be subjected to pathological analysis including correlation study
of fluorescence signal and tumor tissue in pathology slice.
This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG
near-infrared fluorescence imaging and determine the accuracy of regional lymph node
metastasis.