Colon Cancer
Conditions
Keywords
tattooing, localization, colon cancer
Brief summary
* Title of the Study Testing a Fluorescent Surgical Marker Clip for Tumor Localization in Minimally Invasive Colorectal Surgery * Purpose of the Study This study aims to determine if a fluorescent surgical marker clip can accurately and safely localize tumor locations in the colon during minimally invasive colorectal surgery. The study will compare the effectiveness of this clip to the current method using a dye called Indocyanine Green (ICG). The main questions the investigators aim to address are: Can the clip safely and effectively localize tumor sites compared to ICG dye? What side effects or medical issues might arise with the use of the clip? -Study Design Assignment Participants will be randomly assigned to one of two groups: The clip group: A fluorescent clip will be placed near the tumor. The dye group: ICG dye will be injected near the tumor. Procedures Participants will undergo a colonoscopy to mark the tumor location before surgery using either the fluorescent clip or ICG dye. * Follow-Up Participants will attend follow-up visits after surgery to monitor for any side effects or complications. * Eligibility Inclusion Criteria Participants may qualify if: They are 19 years or older. They are scheduled for minimally invasive colorectal surgery for a tumor or suspected tumor. Exclusion Criteria Participants cannot enroll if: They have certain medical conditions, such as blood clotting disorders or allergies to metals or iodine. They are pregnant or breastfeeding. -Participant Role By participating, individuals will contribute to advancing research aimed at improving methods for tumor localization during surgery, potentially leading to enhanced surgical outcomes in the future. For questions or concerns, participants are encouraged to contact the investigators or the research team.
Interventions
PROCEDUREEndoscopic Clipping
localization of colon lesion with fluorescent clip
PROCEDUREICG injection
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 19years or more * With colonic neoplasm planning minimally invasive surgery * Need localization of lesion before surgery
Exclusion criteria
* Planned total proctocolectomy * Contraindication of colonoscopy * On pregnancy or breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of localization | In operation | Accuracy of Identifying the Exact Tumor Location Experimental Group: Considered successful when the tumor can be observed through the applied clips using fluorescence imaging. Control Group: Considered successful when the ICG-tattooed tumor can be observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reconfirmation Rate via Intraoperative Colonoscopy (%) | In operation | The proportion of cases where intraoperative colonoscopy was performed. |
| Total Operation Time (minutes) | From start of operation to end of operation. | The time from skin incision to skin closure. |
| Time Required for Endoscopic Marking Procedure (minutes) | From identifying of tumor in colonoscopy to completing the clipping or injection of ICG | The time from identifying the tumor to completing the attachment of all required clips for marking the tumor or completing the injection of ICG. |
| Longitudinal Length of ICG Spread in the Control Group (mm) | After resection of colon, in operation | In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon. |
Countries
South Korea
Outcome results
None listed