Panaiotti Lidiia, Karachun Aleksei, Muravtseva Anastasia, Petrov Aleksei
Surgical Emergency Unit, John Radcliffe Hospital, OUH, Oxford, United Kingdom.
Surgical Department of Abdominal Oncology, FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Healthcare of Russian Federation, Saint Petersburg, Russian Federation.
Int J Surg Protoc. 2025 Mar 20;29(2):40-47. doi: 10.1097/SP9.0000000000000041. eCollection 2025 Jun.
Optimal extent of lymph node dissection for colon cancer is debatable. Extensive lymphadenectomy may increase complication rate, while limited lymph node dissection may compromise oncological outcome. One of promising ways to find balance is to tailor extent of lymph node dissection to patient's individual anatomy using ICG lymphatic mapping.
This is a single center interventional phase II trial with single group assignment aiming to determine if ICG lymphatic mapping sensitivity is sufficient to guide resection margins selection in colon cancer surgery. The trial's primary endpoint is proportion of pN+ patients in which affected lymph nodes are detected only within margins of ICG spread. Sample size of 101 patients was calculated using Buderer method with a confidence level (1 - ) of 0.95 as a minimum of cases required to test accuracy of lCG lymphatic mapping for estimated sensitivity of 0.99 and precision of 0.03. The average of pN+ cases in our center (42%) was used as prevalence. Secondary endpoints are incidence of adverse events related to ICG lymphatic mapping, feasibility of ICG lymphatic mapping for colon cancer, incidence of lymph node metastases outside conventional resection margins (10 cm), colon cancer lymphatic spread patterns, proportion of operations which extent is affected by ICG lymphatic mapping. The trial is conducted among female or male patients, 18 years or older, with signed informed consent, and diagnosed primary colon cancer. Inclusion criteria include pathologically confirmed adenocarcinoma of the colon, T1-4aN0-2bM0-1b, clinical indications to colonic resection, ECOG - 0-2. Exclusion criteria consist of acute bowel obstruction, bleeding or perforation, adjacent organ invasion or peritoneal carcinomatosis, and contraindications to ICG administration. Eligible patients are allocated for colonic resection with intraoperative ICG mapping. During pathological examination, lymph nodes are assessed for presence of metastases and location in relation to tumor and fluorescence margins. The study began on 26 July 2022 and is conducted in and financed by N.N. Petrov NMRC of Oncology in Saint Petersburg, Russia, it is conducted in.
If after 101 ICG lymphatic mapping procedures, sensitivity of >96% is observed, this will provide rationale behind tailoring resection margins to fit ICG spread.
ICG lymphangiography allows a surgeon to see locoregional lymphatics of a tumor site in real time and tailor colon and mesentery resection margins to meet oncological and functional needs. More data is needed to make this approach more widespread.
结肠癌淋巴结清扫的最佳范围存在争议。广泛淋巴结清扫可能会增加并发症发生率，而有限的淋巴结清扫可能会影响肿瘤学结局。找到平衡的一种有前景的方法是使用吲哚菁绿（ICG）淋巴管造影术根据患者个体解剖结构调整淋巴结清扫范围。
这是一项单中心干预性II期试验，采用单组设计，旨在确定ICG淋巴管造影术的敏感性是否足以指导结肠癌手术中切除边缘的选择。该试验的主要终点是仅在ICG扩散边缘内检测到受累淋巴结的pN+患者的比例。使用布德勒方法计算了101例患者的样本量，置信水平（1-α）为0.95，这是测试ICG淋巴管造影术准确性所需的最少病例数，估计敏感性为0.99，精度为0.03。我们中心pN+病例的平均值（42%）用作患病率。次要终点包括与ICG淋巴管造影术相关的不良事件发生率、ICG淋巴管造影术用于结肠癌的可行性、传统切除边缘（10厘米）外淋巴结转移的发生率、结肠癌淋巴扩散模式、手术范围受ICG淋巴管造影术影响的比例。该试验在签署知情同意书、年龄18岁及以上、诊断为原发性结肠癌的男性或女性患者中进行。纳入标准包括经病理证实的结肠腺癌、T1-4aN0-2bM0-1b、结肠切除的临床指征、东部肿瘤协作组（ECOG）评分0-2。排除标准包括急性肠梗阻、出血或穿孔、相邻器官侵犯或腹膜癌病以及ICG给药的禁忌症。符合条件的患者接受术中ICG造影的结肠切除术。在病理检查期间，评估淋巴结是否存在转移以及与肿瘤和荧光边缘的位置关系。该研究于2022年7月26日开始，在俄罗斯圣彼得堡的N.N.彼得罗夫肿瘤医学研究中心进行并由其资助。
如果在101次ICG淋巴管造影术后观察到敏感性>96%，这将为根据ICG扩散调整切除边缘提供理论依据。
ICG淋巴管造影术使外科医生能够实时看到肿瘤部位的局部淋巴管，并调整结肠和肠系膜切除边缘以满足肿瘤学和功能需求。需要更多数据以使这种方法更广泛应用。
