ICG-coated Endoscopic Clip for Tumor Localization
November 26, 2019 updated by: Dae Kyung Sohn, National Cancer Center, Korea
The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
- National Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ICG clip
Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery
|
Tumor localization using ICG-coated clip prior to surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate of localization
Time Frame: through study completion, an average of 1 year
|
The rate of Identifying ICG-coated clip during surgery
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
loss rate of clips
Time Frame: through study completion, an average of 1 year
|
The rate of detachment of clips before surgery
|
through study completion, an average of 1 year
|
|
Number of Participants with Complication
Time Frame: through study completion, an average of 1 year
|
Procedure-related complication
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: DAE KYUNG SOHN, National Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2019
Primary Completion (Actual)
November 20, 2019
Study Completion (Actual)
November 26, 2019
Study Registration Dates
First Submitted
April 17, 2019
First Submitted That Met QC Criteria
April 22, 2019
First Posted (Actual)
April 23, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2019
Last Update Submitted That Met QC Criteria
November 26, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC2019-0046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.