ICG-coated Endoscopic Clip for Tumor Localization

Colorectal Neoplasms Clinical Trial

Official title:

The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924349
• Other study ID #: NCC2019-0046
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: November 26, 2019

Study information

• Verified date: November 2019
• Source: National Cancer Center, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 26, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• ICG-coated clip
Tumor localization using ICG-coated clip prior to surgery

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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: 10.1080/13645706.2018.15 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of localization	The rate of Identifying ICG-coated clip during surgery	through study completion, an average of 1 year
Secondary	loss rate of clips	The rate of detachment of clips before surgery	through study completion, an average of 1 year
Secondary	Number of Participants with Complication	Procedure-related complication	through study completion, an average of 1 year