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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG clip | Experimental | Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICG-coated clip | Device | Tumor localization using ICG-coated clip prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Success rate of localization | The rate of Identifying ICG-coated clip during surgery | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| loss rate of clips | The rate of detachment of clips before surgery | through study completion, an average of 1 year |
| Number of Participants with Complication | Procedure-related complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DAE KYUNG SOHN | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26895900 | Result | Hyun JH, Kim SK, Kim KG, Kim HR, Lee HM, Park S, Kim SC, Choi Y, Sohn DK. A novel endoscopic fluorescent band ligation method for tumor localization. Surg Endosc. 2016 Oct;30(10):4659-63. doi: 10.1007/s00464-016-4785-1. Epub 2016 Feb 19. | |
| 21298528 | Result | Choi Y, Kim KG, Kim JK, Nam KW, Kim HH, Sohn DK. A novel endoscopic fluorescent clip for the localization of gastrointestinal tumors. Surg Endosc. 2011 Jul;25(7):2372-7. doi: 10.1007/s00464-010-1557-1. Epub 2011 Feb 7. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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Prospective single center open label early phase clinical trial
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| through study completion, an average of 1 year |
| 30513228 | Result | Hyun JH, Han KS, Kim BC, Hong CW, Oh JH, Park SC, Kim MJ, Sohn DK. Preoperative endoscopic clipping for rectal tumor localization in laparoscopic anterior resection. Minim Invasive Ther Allied Technol. 2019 Dec;28(6):326-331. doi: 10.1080/13645706.2018.1547765. Epub 2018 Dec 4. |
| 30048996 | Result | Lee SJ, Sohn DK, Han KS, Kim BC, Hong CW, Park SC, Kim MJ, Park BK, Oh JH. Preoperative Tattooing Using Indocyanine Green in Laparoscopic Colorectal Surgery. Ann Coloproctol. 2018 Aug;34(4):206-211. doi: 10.3393/ac.2017.09.25. Epub 2018 Jul 26. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |