Colorectal Neoplasms
Conditions
Brief summary
The fluorescent clipping method involves endoscopic clipping a fluorescent clip into the colonic lesion site in advance of surgery, and observing the position of the fluorescence through the colonic wall by a light source of a certain wavelength band during surgery. The purpose of this study is to evaluate the efficacy of the localization of colonic lesions using ICG coated endoscopic clip in laparoscopic colon surgery.
Interventions
DEVICEICG-coated clip
Tumor localization using ICG-coated clip prior to surgery
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective single center open label early phase clinical trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Cases which are deemed necessary to mark the location of the colon lesion before surgery
Exclusion criteria
* Preoperative colonoscopy is not possible due to intestinal obstruction * If the lesion is located in the rectal area and the lesion can be confirmed by digital rectal exam * disagreement with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of localization | through study completion, an average of 1 year | The rate of Identifying ICG-coated clip during surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| loss rate of clips | through study completion, an average of 1 year | The rate of detachment of clips before surgery |
| Number of Participants with Complication | through study completion, an average of 1 year | Procedure-related complication |
Countries
South Korea
Outcome results
None listed