Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.

Enrolling by invitation · Not applicable

Conditions studied: Colorectal Cancer, Endoscopic Tattoo of Suspected Colon Cancer, Indocyanine Green (ICG)

In brief

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.

Key facts

Study ID

NCT07380867

Run by

Seoul St. Mary's Hospital

People needed

30

Starts

2025-12-22

Expected to finish

2026-12-31

Last updated by the study team

2026-02-02

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Seoul St.Mary's hospital, the Catholic university of Korea — Seoul, Seoul, South Korea

Full record on ClinicalTrials.gov

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