A Prospective Study of Indocyanine Green (ICG) Fluorescence-Guided Lymphatic Mapping During Laparoscopic Colon Cancer Resection
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
研究概览
简要总结
The aim of this study is to evaluate the role of indocyanine green (ICG) injection in fluorescence-guided lymphatic mapping during laparoscopic colon cancer resection. This is a single-center prospective single-arm pilot clinical study that will include at least 25 patients with resectable colon cancer. All enrolled patients will undergo intraoperative subserosal ICG-guided lymphatic mapping before dissection, and intravenous ICG perfusion assessment before anastomosis. The primary goal is to determine the proportion of analyzable pN+ patients in whom all metastatic lymph nodes identified on final histopathology are located within the ICG-mapped lymphatic basin.
详细描述
Adequate lymphadenectomy is a key component of curative colon cancer surgery because lymph node status is essential for accurate staging and postoperative treatment planning. Indocyanine green (ICG) fluorescence imaging has become increasingly used intraoperatively to make otherwise invisible lymphatic pathways visible in real time.
Preoperative and Perioperative Care:
All patients will undergo standard preoperative evaluation including colonoscopy with biopsy confirmation, baseline laboratory investigations, carcinoembryonic antigen measurement, and contrast-enhanced CT staging. Perioperative care will follow an enhanced recovery pathway including counseling, thromboembolism prophylaxis, antibiotic prophylaxis, multimodal analgesia, early mobilization, and early oral intake.
Operative Protocol:
Laparoscopic oncologic colectomy will be performed according to tumor location. Fluorescence imaging will be performed using the KARL STORZ IMAGE1 STM Rubina platform. Indocyanine green will be injected subserosally around the tumor in four quadrants whenever feasible. Near-infrared imaging will then be used to identify lymphatic channels and nodal basins before definitive mesenteric division. Any fluorescence-related modification of the extent of mesenteric excision or pedicle clearance will be recorded prospectively. Before bowel anastomosis, intravenous indocyanine green will be used to assess perfusion of the bowel ends by near-infrared fluorescence imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 18 years.
- •- Histologically confirmed colon adenocarcinoma.
排除标准
- •Emergency surgery (obstruction/perforation with sepsis) requiring urgent operation.
- •Known allergy or contraindication to ICG (including prior anaphylaxis to ICG; severe hypersensitivity history per anesthesia assessment).
- •Pregnancy or breastfeeding.
- •Severe hepatic failure (because ICG clearance is hepatobiliary) or other contraindication determined by anesthesia team.
- •Planned palliative resection only.
- •ASA physical status IV or patients otherwise deemed unfit for elective curative colectomy.
研究组 & 干预措施
ICG-Guided Surgery
All patients enrolled in this single-arm study will undergo intraoperative subserosal injection of Indocyanine Green (ICG) for fluorescence-guided lymphatic mapping prior to mesenteric dissection. Additionally, an intravenous ICG injection will be administered to assess bowel perfusion before creating the anastomosis during laparoscopic colon cancer resection.
干预措施: Indocyanine green (ICG) injection for intraoperative lymph node imaging (Drug)
研究者
Kirollos Samir Fathy Messiha
ِAssistant lecturer
Tanta University