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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- Success rate of localization
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19years or more
- •With colonic neoplasm planning minimally invasive surgery
- •Need localization of lesion before surgery
排除标准
- •Planned total proctocolectomy
- •Contraindication of colonoscopy
- •On pregnancy or breast-feeding
研究组 & 干预措施
Clip group
Patients who are underwent localization of colon lesion with fluorescent clip
干预措施: Endoscopic Clipping (Procedure)
ICG group
Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method
干预措施: ICG injection (Procedure)
结局指标
主要结局
Success rate of localization
时间窗: In operation
Accuracy of Identifying the Exact Tumor Location Experimental Group: Considered successful when the tumor can be observed through the applied clips using fluorescence imaging. Control Group: Considered successful when the ICG-tattooed tumor can be observed.
次要结局
- Reconfirmation Rate via Intraoperative Colonoscopy (%)(In operation)
- Total Operation Time (minutes)(From start of operation to end of operation.)
- Time Required for Endoscopic Marking Procedure (minutes)(From identifying of tumor in colonoscopy to completing the clipping or injection of ICG)
- Longitudinal Length of ICG Spread in the Control Group (mm)(After resection of colon, in operation)