NCT03924349

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 23, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 8, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

November 27, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

April 17, 2019

Last Update Submit

November 26, 2019

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Success rate of localization

    The rate of Identifying ICG-coated clip during surgery

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • loss rate of clips

    through study completion, an average of 1 year

  • Number of Participants with Complication

    through study completion, an average of 1 year

Study Arms (1)

ICG clip

EXPERIMENTAL

Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery

Device: ICG-coated clip

Interventions

ICG-coated clipDEVICE

Tumor localization using ICG-coated clip prior to surgery

ICG clip

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases which are deemed necessary to mark the location of the colon lesion before surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 26895900RESULT

  • 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.

    PMID: 21298528RESULT

  • 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.

    PMID: 30513228RESULT

  • 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.

    PMID: 30048996RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • DAE KYUNG SOHN

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective single center open label early phase clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 23, 2019

Study Start

July 8, 2019

Primary Completion

November 20, 2019

Study Completion

November 26, 2019

Last Updated

November 27, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)