Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial

Jianting Du, Guobing Xu, Zhang Yang, Bin Zheng, Chun Chen, Jianting Du, Guobing Xu, Zhang Yang, Bin Zheng, Chun Chen

Abstract

Introduction: 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.

Keywords: esophageal cancer; indocyanine green; lymphadenectomy; randomized controlled trial; sentinel lymph node.

Conflict of interest statement

None declared.

© 2022 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

Figures

FIGURE 1
FIGURE 1
Trial design. ICG, indocyanine green

References

    1. Bredell MG. Sentinel lymph node mapping by indocyanin green fluorescence imaging in oropharyngeal cancer ‐ preliminary experience. Head Neck Oncol. 2010;2:31. 10.1186/1758-3284-2-31
    1. Van der Vorst JR, Schaafsma BE, Verbeek FPR, et al. Nearinfrared fluorescence sentinel lymph node mapping of the oral cavity in head and neck cancer patients. Oral Oncol. 2013;49:15–9. 10.1016/j.oraloncology.2012.11.010
    1. Atallah I, Milet C, Quatre R, Henry M, Reyt E, Coll JL, et al. Role of near‐infrared fluorescence imaging in the resection of metastatic lymph nodes in an optimized orthotopic animal model of HNSCC. Eur Ann Otorhinolaryngol Head Neck Dis. 2015;132:337–42. 10.1016/j.anorl.2015.08.022
    1. Digonnet A, van Kerckhove S, Moreau M, Willemse E, Quiriny M, Ahmed B, et al. Near infrared fluorescent imaging after intravenous injection of indocyanine green during neck dissection in patients with head and neck cancer: a feasibility study. Head Neck. 2016;38(Suppl 1):E1833–7. 10.1002/hed.24331
    1. Hosch SB, Stoecklein NH, Pichlmeier U, Rehders A, Scheunemann P, Niendorf A, et al. Esophageal cancer: the mode of lymphatic tumor cell spread and its prognostic significance. J Clin Oncol. 2001;19:1970–5.
    1. Sonohara F, Gao F, Iwata N, Kanda M, Koike M, Takahashi N, et al. Genome‐wide discovery of a novel gene‐expression signature for the identification of lymph node metastasis in esophageal squamous cell carcinoma. Ann Surg. 2019;269(5):879–86. 10.1097/SLA.0000000000002622
    1. Nigro JJ, DeMeester SR, Hagen JA, et al. Node status in transmural esophageal adenocarcinoma and outcome after en bloc esophagectomy. J Thorac Cardiovasc Surg. 1999;117(5):960–8. 10.1016/S0022-5223(99)70377-6
    1. Rice TW, Zuccaro G Jr, Adelstein DJ, Rybicki LA, Blackstone EH, Goldblum JR. Esophageal carcinoma: depth of tumor invasion is predictive of regional lymph node status. Ann Thorac Surg. 1998;65(3):787–92. 10.1016/s0003-4975(97)01387-8
    1. Tachibana M, Kinugasa S, Shibakita M, Tonomoto Y, Hattori S, Hyakudomi R, et al. Surgical treatment of superficial esophageal cancer. Langenbecks Arch Surg. 2006;391(4):304–21. 10.1007/s00423-006-0063-3
    1. Wu Y, Jing J, Wang J, Xu B, Du M, Chen M. Robotic‐assisted sentinel lymph node mapping with Indocyanine green in pelvic malignancies: a systematic review and meta‐analysis. Front Oncol. 2019;9:585. 10.3389/fonc.2019.00585
    1. He K, Zhou J, Yang F, et al. Near‐infrared intraoperative imaging of thoracic sympathetic nerves: from preclinical study to clinical trial. Theranostics. 2018;8(2):304–13. 10.7150/thno.22369
    1. Bennett ZT, Feng Q, Bishop JA, Huang G, Sumer BD, Gao J. Detection of lymph node metastases by ultra‐pH‐sensitive polymeric nanoparticles. Theranostics. 2020;10(7):3340–50. 10.7150/thno.41239
    1. Guo J, Yang H, Wang S, et al. Comparison of sentinel lymph node biopsy guided by indocyanine green, blue dye, and their combination in breast cancer patients: a prospective cohort study. World J Surg Oncol. 2017;15(1):196. 10.1186/s12957-017-1264-7
    1. Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, et al. Safety and efficacy of Indocyanine green tracer‐guided lymph node dissection during laparoscopic radical gastrectomy in patients with gastric cancer: a randomized clinical trial. JAMA Surg. 2020;155(4):300–11. 10.1001/jamasurg.2019.6033

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi