Back to resultsICG-coated Endoscopic Clip for Tumor Localization
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ICG-coated clip
Sponsored by
About this trial
This is an interventional other trial for Colorectal Neoplasms
Eligibility Criteria
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
Sites / Locations
- National Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICG clip
Arm Description
Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery
Outcomes
Primary Outcome Measures
Success rate of localization
The rate of Identifying ICG-coated clip during surgery
Secondary Outcome Measures
loss rate of clips
The rate of detachment of clips before surgery
Number of Participants with Complication
Procedure-related complication
Full Information
NCT ID
NCT03924349
First Posted
April 17, 2019
Last Updated
November 26, 2019
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03924349
Brief Title
ICG-coated Endoscopic Clip for Tumor Localization
Official Title
The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 8, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective single center open label early phase clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICG clip
Arm Type
Experimental
Arm Description
Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery
Intervention Type
Device
Intervention Name(s)
ICG-coated clip
Intervention Description
Tumor localization using ICG-coated clip prior to surgery
Primary Outcome Measure Information:
Title
Success rate of localization
Description
The rate of Identifying ICG-coated clip during surgery
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
loss rate of clips
Description
The rate of detachment of clips before surgery
Time Frame
through study completion, an average of 1 year
Title
Number of Participants with Complication
Description
Procedure-related complication
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DAE KYUNG SOHN
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26895900
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.
Results Reference
result
PubMed Identifier
21298528
Citation
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.
Results Reference
result
PubMed Identifier
30513228
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: 10.1080/13645706.2018.1547765. Epub 2018 Dec 4.
Results Reference
result
PubMed Identifier
30048996
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.
Results Reference
result
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ICG-coated Endoscopic Clip for Tumor Localization
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