Detection Rate of SLN ; Accuracy Rate of Lymph Node Metastasis Clinical Trial
Official title:
Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery ：a Single-arm Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 84 |
| Est. completion date | November 30, 2021 |
| Est. primary completion date | November 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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; |
| Country | Name | City | State |
|---|---|---|---|
| China | The Fifth Affiliated Hospital of Sun Yat-sen University | Zhuhai | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Fifth Affiliated Hospital, Sun Yat-Sen University | Sun Yat-sen University |
China,
Hayami S, Matsuda K, Iwamoto H, Ueno M, Kawai M, Hirono S, Okada K, Miyazawa M, Tamura K, Mitani Y, Kitahata Y, Mizumoto Y, Yamaue H. Visualization and quantification of anastomotic perfusion in colorectal surgery using near-infrared fluorescence. Tech Co — View Citation
Lerut T, Nafteux P, Moons J, Coosemans W, Decker G, De Leyn P, Van Raemdonck D, Ectors N. Three-field lymphadenectomy for carcinoma of the esophagus and gastroesophageal junction in 174 R0 resections: impact on staging, disease-free survival, and outcome: — View Citation
Lim HJ, Chiow AKH, Lee LS, Tan SS, Goh BK, Koh YX, Chan CY, Lee SY. Novel method of intraoperative liver tumour localisation with indocyanine green and near-infrared imaging. Singapore Med J. 2019 Nov 4. doi: 10.11622/smedj.2019137. [Epub ahead of print] — View Citation
Pennathur A, Gibson MK, Jobe BA, Luketich JD. Oesophageal carcinoma. Lancet. 2013 Feb 2;381(9864):400-12. doi: 10.1016/S0140-6736(12)60643-6. Review. — View Citation
Predina JD, Newton AD, Corbett C, Shin M, Sulfyok LF, Okusanya OT, Delikatny EJ, Nie S, Gaughan C, Jarrar D, Pechet T, Kucharczuk JC, Singhal S. Near-infrared intraoperative imaging for minimally invasive pulmonary metastasectomy for sarcomas. J Thorac Ca — View Citation
Rice TW, Apperson-Hansen C, DiPaola LM, Semple ME, Lerut TE, Orringer MB, Chen LQ, Hofstetter WL, Smithers BM, Rusch VW, Wijnhoven BP, Chen KN, Davies AR, D'Journo XB, Kesler KA, Luketich JD, Ferguson MK, Räsänen JV, van Hillegersberg R, Fang W, Durand L, — View Citation
Shirakawa S, Toyama H, Kido M, Fukumoto T. A prospective single-center protocol for using near-infrared fluorescence imaging with indocyanine green during staging laparoscopy to detect small metastasis from pancreatic cancer. BMC Surg. 2019 Nov 7;19(1):16 — View Citation
Taniyama Y, Nakamura T, Mitamura A, Teshima J, Katsura K, Abe S, Nakano T, Kamei T, Miyata G, Ouchi N. A strategy for supraclavicular lymph node dissection using recurrent laryngeal nerve lymph node status in thoracic esophageal squamous cell carcinoma. A — View Citation
Yamada Y, Ohno M, Fujino A, Kanamori Y, Irie R, Yoshioka T, Miyazaki O, Uchida H, Fukuda A, Sakamoto S, Kasahara M, Matsumoto K, Fuchimoto Y, Hoshino K, Kuroda T, Hishiki T. Fluorescence-Guided Surgery for Hepatoblastoma with Indocyanine Green. Cancers (B — View Citation
Yanagi Y, Yoshimaru K, Matsuura T, Shibui Y, Kohashi K, Takahashi Y, Obata S, Sozaki R, Izaki T, Taguchi T. The outcome of real-time evaluation of biliary flow using near-infrared fluorescence cholangiography with Indocyanine green in biliary atresia surg — View Citation
Zhou SC, Tian YT, Wang XW, Zhao CD, Ma S, Jiang J, Li EN, Zhou HT, Liu Q, Liang JW, Zhou ZX, Wang XS. Application of indocyanine green-enhanced near-infrared fluorescence-guided imaging in laparoscopic lateral pelvic lymph node dissection for middle-low r — View Citation
* Note: There are 11 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the detection rate of sentinel lymph node | the detection rate of sentinel lymph node in all the enrolled patients | through study completion, an average of 1 year | |
| Primary | The positive rate of sentinel lymph node | the positive rate of sentinel lymph node in all the enrolled patients | through study completion, an average of 1 year |