Open AccessPericancerous lymph node imaging with indocyanine green‐guided near‐infrared fluorescence in radical esophagectomy: Protocol for a single‐center, prospective, randomized controlled clinical trial
Author(s) -
Du Jianting,
Xu Guobing,
Yang Zhang,
Zheng Bin,
Chen Chun
Publication year - 2022
Publication title -
thoracic cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.823
H-Index - 28
eISSN - 1759-7714
pISSN - 1759-7706
DOI - 10.1111/1759-7714.14548
Subject(s) - medicine , esophageal cancer , esophagectomy , indocyanine green , lymphadenectomy , lymph node , dissection (medical) , radiology , sentinel lymph node , lymph , surgery , neoadjuvant therapy , cancer , pathology , breast cancer
The incidence and mortality rates of esophageal carcinoma are higher than those of most malignancies in humans. Radical esophagectomy is the preferred treatment for early‐stage esophageal cancer. However, the extent of lymphadenectomy during radical esophagectomy remains controversial. Indocyanine green (ICG) is the most commonly used imaging agent for the diagnosis of tumors and metastatic lymph nodes in clinical settings. Thus, the main aim of this study was to evaluate pericancerous lymph nodes imaging in video‐assisted thoracoscopic surgery radical esophagectomy using a near‐infrared (NIR) ICG imaging system and to improve the detection rate of sentinel lymph nodes (SLNs) and overall survival of patients with esophageal cancer. Methods This was a single‐center, prospective, randomized controlled clinical trial (allocation rate = 1:1). Forty treatment‐naive esophageal cancer patients were recruited and divided into two groups: the ICG and control groups. The inclusion criteria were age, absence of preoperative neoadjuvant therapy, elective surgery, and signed informed consent. Data of participants at four different time points (preoperation, intraoperation, postoperative 1 week and 3 months) were collected and recorded. The main endpoint of this study was to explore the accuracy and false‐negative rate of lymphadenectomy using NIR‐ICG fluorescence imaging and to identify the location of esophageal cancer SLN combined with postoperative pathological reports. Discussion This trial will provide more evidence on the extent of lymph node dissection for esophageal cancer and contribute to the development of treatment guidelines for esophageal cancer. Trial registration number NCT04615806.