Clinical trial · Interventional
Confirming the Accuracy of Endoscopic Marking Using a New Marker, a Novel Luminomarker, in Lesion Marking Before Colorectal Cancer Surgery.
Localization of Preoperative Endoscopic Tattooing Using Indocyanine Green(ICG)-Hyaluronic Acid Mixture (Luminomark) for Colorectal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Endoscopic Tattoo of Suspected Colon Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LuminoMark inj. 0.2mL | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Luminomarker injection
- description
- Through endoscopy, Luminomarker injection on submucosal layer. Location of injection : total 4 sites around tumor 1. Left lateral side of tumor 2. Right lateral side of tumor 3. opposite of tumor (180 degree) 4. distal part of 2cm from the tumor dosage of injection : at least 0.5cc per a site , total 2cc
- interventionNames
- Drug: LuminoMark inj. 0.2mL
Primary outcomes (1)
- measure
- Distance between endoscopic lesion markings and lesion location markings using luminomarkers for accuracy of tattooing
- timeFrame
- Perioperative/Periprocedural
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available