Sentinel Lymph Node Navigation Surgery Using Near-infrared Indocyanine Green Imaging in Early Esophageal Cancer
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|ClinicalTrials.gov Identifier: NCT04173676|
Recruitment Status : Recruiting
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
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 a single-center and one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 50 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 upper 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.
|Condition or disease||Intervention/treatment||Phase|
|Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis||Drug: Indocyanine Green for Injection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||155 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The sentinel lymph nodes are observed by submucosal injection of ICG|
|Masking:||None (Open Label)|
|Official Title:||Sentinel Lymph Node Navigation Using Near-infrared Indocyanine Green Imaging in Radical Esophagectomy of Single-Port Inflatable Mediastinoscopy Combined With Laparoscopy Surgery ：a Single-arm Clinical Trial|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||November 30, 2021|
Experimental: use of indocyanine green
submucosal injection of ICG is by gastroscopy on the upper edge of the esophageal tumor,Dose of 0.5mg
Drug: Indocyanine Green for Injection
The sentinel lymph nodes were observed by submucosal injection of ICG
- the detection rate of sentinel lymph node [ Time Frame: through study completion, an average of 1 year ]the detection rate of sentinel lymph node in all the enrolled patients
- The positive rate of sentinel lymph node [ Time Frame: through study completion, an average of 1 year ]the positive rate of sentinel lymph node in all the enrolled patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173676
|Contact: Hong Shan, PhDfirstname.lastname@example.org|
|The Fifth Affiliated Hospital of Sun Yat-sen University||Recruiting|
|Zhuhai, Guangdong, China, 519000|
|Contact: Xiaojin Wang, MD +86-13798967219 email@example.com|