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ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group

ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group

ICG will be injected to participants preoperatively for molecular fluorescence image

Indocyanine green for injection

Chihua Fang, MD

Xiaojun Zeng

Chihua Fang, M.D

The of this study is to explore the clinical outcomes of indocyanine green molecular fluorescence imaging in local resection of primary hepatocellular carcinoma (CNLC Ⅰa stage).

Indocyanine green molecular imaging technique is often used in the surgical treatment of primary liver cancer. Its application in hepatectomy of primary liver cancer is currently in the stage of case accumulation and clinical research. No prospective study has been conducted to determine the clinical efficacy of indocyanine green molecular imaging for local hepatectomy of primary liver cancer. On the basis of more than 1000 liver resection procedures, the investigators want to apply indocyanine green molecular imaging technology, a cheap, simple and radiation-free method, to guide surgical resection. The purpose is to assist surgical procedures and improve participants' tumor-free survival.

Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer

Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer

No tumor recurrence within 3 years after surgery divided by total number of patients

Compare positive margin rate in both groups

Compare negative margin rate in both groups

The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis

Compare intraoperative blood loss in both groups

Compare intraoperative blood transfusion volume in both groups

Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group

The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group

The number of cases of successful intraoperative detection of biliary fistula by fluorescence in the intervention group divided by the total number of cases in the intervention group.

The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group

Compare Postoperative hospital stay in both groups. Eg: Postoperative hospital stay is the number of days from the day of surgery to the day of discharge.

Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups

Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups

Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups

Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups

Compare hemoglobin on postoperative days 1, 3, and 5 in both groups

Compare platelets on postoperative days 1, 3, and 5 in both groups

Compare prothrombin time on postoperative days 1, 3, and 5 in both groups

Perioperative death was defined as death occurring within 90 days after surgery

Zhujiang Hospital

Clinical Professor

Symptoms and General Pathology

Neoplasm Metastasis

Esophageal Neoplasms

Lymphatic Metastasis

Neoplastic Processes

Esophageal Cancer

submucosal injection of ICG is by gastroscopy on the superior and inferior edge of the esophageal tumor,Dose of 0.5mg

The sentinel lymph nodes were observed by submucosal injection of ICG

Indocyanine Green for Injection

Hong Shan, PhD

Xiaojin Wang, MD

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.

The sentinel lymph nodes are observed by submucosal injection of ICG

Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer

Sentinel Lymph Node Navigation Using Near-infrared Imaging in Radical Esophagectomy Surgery ：a Single-arm Clinical Trial

the detection rate of sentinel lymph node in all the enrolled patients

the positive rate of sentinel lymph node in all the enrolled patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	NCT05160740	Liver Cancer	Indocyanine gre...	18 Years - 66 Years	Zhujiang Hospital
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	NCT05160740	Liver Cancer	Indocyanine gre...	18 Years - 66 Years	Zhujiang Hospital
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer	NCT05160740	Liver Cancer	Indocyanine gre...	18 Years - 66 Years	Zhujiang Hospital
Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer	NCT04173676	Detection Rate ...	Indocyanine Gre...	18 Years - 75 Years	Fifth Affiliated Hospital, Sun Yat-Sen University

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