Clinical trial NCT06714292: Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure
Official title: Efficacy and Safety of Fluorescent Surgical Marker Clip for Tumor Localization in Laparoscopic Colorectal Surgery for Colorectal Cancer Patients
        : Multi-center, Randomized, Single-blind, Prospective, Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colon Cancer
Keywords: tattooing
localization
colon cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 110
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: * Title of the Study Testing a Fluorescent Surgical Marker Clip for Tumor Localization in Minimally Invasive Colorectal Surgery
* Purpose of the Study This study aims to determine if a fluorescent surgical marker clip can accurately and safely localize tumor locations in the colon during minimally invasive colorectal surgery. The study will compare the effectiveness of this clip to the current method using a dye called Indocyanine Green (ICG).

The main questions the investigators aim to address are:

Can the clip safely and effectively localize tumor sites compared to ICG dye? What side effects or medical issues might arise with the use of the clip?

-Study Design Assignment

Participants will be randomly assigned to one of two groups:

The clip group: A fluorescent clip will be placed near the tumor. The dye group: ICG dye will be injected near the tumor.

Procedures Participants will undergo a colonoscopy to mark the tumor location before surgery using either the fluorescent clip or ICG dye.

* Follow-Up Participants will attend follow-up visits after surgery to monitor for any side effects or complications.
* Eligibility Inclusion Criteria

Participants may qualify if:

They are 19 years or older. They are scheduled for minimally invasive colorectal surgery for a tumor or suspected tumor.

Exclusion Criteria

Participants cannot enroll if:

They have certain medical conditions, such as blood clotting disorders or allergies to metals or iodine.

They are pregnant or breastfeeding.

-Participant Role By participating, individuals will contribute to advancing research aimed at improving methods for tumor localization during surgery, potentially leading to enhanced surgical outcomes in the future.

For questions or concerns, participants are encouraged to contact the investigators or the research team.


Eligibility criteria: Inclusion Criteria:

* Aged 19years or more
* With colonic neoplasm planning minimally invasive surgery
* Need localization of lesion before surgery

Exclusion Criteria:

* Planned total proctocolectomy
* Contraindication of colonoscopy
* On pregnancy or breast-feeding

Primary outcomes:
measure: Success rate of localization
timeFrame: In operation
Secondary outcomes:
measure: Reconfirmation Rate via Intraoperative Colonoscopy (%)
timeFrame: In operation
measure: Total Operation Time (minutes)
timeFrame: From start of operation to end of operation.
measure: Time Required for Endoscopic Marking Procedure (minutes)
timeFrame: From identifying of tumor in colonoscopy to completing the clipping or injection of ICG
measure: Longitudinal Length of ICG Spread in the Control Group (mm)
timeFrame: After resection of colon, in operation
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Ji Won Park, M.D.
role: PRINCIPAL_INVESTIGATOR
References: