Colorectal CancerEndoscopic Tattoo of Suspected Colon CancerIndocyanine Green (ICG)
Investigational drug(s) / intervention(s)
LuminoMark inj. 0.2mL
LuminoMark inj. 0.2mL: * Endoscopic tattooing with Luminomark on submucosal layer of bowel
* Location of injection : total 4 sites
1. Left lateral side of the tumor
2. Right lateral side of the tumor
3. opposite side of the tumor
4. distal side of the tumor
* Dosage of injection: -at least 0.5cc per a site, total 2ml
Study summary
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.
Eligibility
Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing — 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.
Trial sites (1)
Facility
City
Region
Status
Seoul St.Mary's hospital, the Catholic university of Korea
Seoul
Seoul
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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