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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clip group | Experimental | Patients who are underwent localization of colon lesion with fluorescent clip |
|
| ICG group | Active Comparator | Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Clipping | Procedure | localization of colon lesion with fluorescent clip |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of localization | 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. | In operation |
| Measure | Description | Time Frame |
|---|---|---|
| Reconfirmation Rate via Intraoperative Colonoscopy (%) | The proportion of cases where intraoperative colonoscopy was performed. | In operation |
| Total Operation Time (minutes) | The time from skin incision to skin closure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Won Park, M.D. | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 10408 | South Korea | ||
| Seoul National University Hospital |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ICG injection |
| Procedure |
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing |
|
|
| From start of operation to end of operation. |
| Time Required for Endoscopic Marking Procedure (minutes) | The time from identifying the tumor to completing the attachment of all required clips for marking the tumor or completing the injection of ICG. | From identifying of tumor in colonoscopy to completing the clipping or injection of ICG |
| Longitudinal Length of ICG Spread in the Control Group (mm) | In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon. | After resection of colon, in operation |
| Seoul |
| 03080 |
| South Korea |
| Seoul Boramae Medical Center | Seoul | 07061 | South Korea |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |