Localization of Preoperative Endoscopic Tattooing Using Indocyanine Green(ICG)-Hyaluronic Acid Mixture (Luminomark) for Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing
研究概览
简要总结
Early-stage lesions are difficult to identify intraoperatively during colorectal cancer surgery. Therefore, preoperative lesion marking using a colonoscopic approach is crucial to confirm the location and extent of resection during surgery. Preoperative lesion location can help determine the optimal extent of resection, thereby increasing the accuracy of colorectal surgery. This is particularly true for cases requiring surgery after early-stage colorectal cancer or endoscopic tumor resection. Therefore, preoperative marking with indocyanine green (IDG) allows for laparoscopic identification of the lesion. This is crucial because it allows for precise lesion location, thereby enhancing surgical accuracy and preventing the need for unnecessary additional resections.
详细描述
The recently developed indocyanine green (ICG)-hyaluronic acid mixture (LuminoMark™, Hanlim Pharm Co., Seoul, Republic of Korea) is a surgical marker combining indocyanine green with macroaggregated albumin (MAA). Its non-diffusing properties allow for precise lesion targeting. It addresses unmet needs of existing surgical markers, such as skin pigmentation and surgical site contamination. It effectively adsorbs onto cancerous lesions, enabling precise lesion location. Real-time tracking of the pigment allows for clear identification of the lesion's extent of removal, enhancing convenience and usability during surgery. It has already demonstrated superiority over existing labeling methods in a phase 3 clinical trial for breast lesions, receiving approval from the Ministry of Food and Drug Safety. Clinical trials are underway for various cancer types, including gastric and colon cancer, but it remains an over-approved drug.
Therefore, this study aimed to determine the accuracy of endoscopic labeling using a novel luminomarker for preoperative colon cancer lesion marking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 19-80 years
- •Clinical T1-2, N0, without distant metastasis on imaging
- •If surgical treatment is required after ESD (endoscopic mucosal resection)*
- •If endoscopic lesion marking is required as determined by the attending physician
排除标准
- •Patients diagnosed with distant metastases (M1)
- •Severe hepatic or renal dysfunction (Child-Pugh Class C, eGFR <39 mL/min/1.73 m2)
- •Pregnant or lactating women
- •High risk of intestinal obstruction or perforation
- •Patients deemed inappropriate by the investigator (high-risk patients, such as patients with lung or heart disease, risk factors for bleeding, hepatitis virus infection, or other cancers)
- •Patients with a history of hypersensitivity to the luminomarker drug or its components
- •Patients who have experienced skin hypersensitivity to the dye
- •Patients who do not wish to participate in the study
研究组 & 干预措施
Luminomarker injection
Through endoscopy, Luminomarker injection on submucosal layer. Location of injection : total 4 sites around tumor
- Left lateral side of tumor
- Right lateral side of tumor
- opposite of tumor (180 degree)
- distal part of 2cm from the tumor
dosage of injection : at least 0.5cc per a site , total 2cc
干预措施: LuminoMark inj. 0.2mL (Drug)
结局指标
主要结局
Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing
时间窗: Perioperative/Periprocedural
* Mix 1 vial (2 ml) of Indocyanine Green (ICG) + Hyaluronic Acid Mixture (Luminomarker™) with 1 vial (2 ml) of the attached solvent. Shake gently to dissolve thoroughly. * After performing an endoscopy to identify the lesion, attach the syringe to the endoscopic injector and mark at least three locations with at least 0.2 cc each. * After general anesthesia, insert a trocar for laparoscopic or robotic surgery and insert the laparoscopic equipment. Use a Laparoscopic near-intrared (NIR) camera to confirm the lesion marking. After marking with a surgical hemoclip, take a photograph and mark with a hemoclipping. A tumor is confirmed at the ICG-marked location in the obtained specimen.
次要结局
- post-procedure related complication(through postoperative 4 days)
研究者
In Kyeong Kim
Clinical Assistant Professor
Seoul St. Mary's Hospital