Clinical trial NCT04173676: Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer
Official title: Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery ：a Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2019-11-22
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The sentinel lymph nodes are observed by submucosal injection of ICG
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, gender is not limited;
2. patient who is diagnosed with ESCC and choose to proceed with surgery
3. patient with cTNM stage:T1-3N0-1M0
4. tumor located at the middle thoracic or lower thoracic esophagus
5. The main organ function is basically normal: Karnofsky score \>70%;
6. Laboratory blood tests meet surgical standards;

Exclusion Criteria:

1. pregnancy or breastfeeding
2. history of iodide or seafood allergy,
3. Patient with occult metastatic disease at the time of surgery
4. patient with mental disorder;
5. Patient who is simultaneously involved in another clinical trial;

Primary outcomes:
measure: the detection rate of sentinel lymph node
timeFrame: through study completion, an average of 1 year
measure: The positive rate of sentinel lymph node
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
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