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临床试验/NCT02702843
NCT02702843已完成不适用

Efficacy Of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) During Laparoscopic Cholecystectomy

The Cleveland Clinic13 个研究点 分布在 5 个国家目标入组 677 人开始时间: 2016年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
677
试验地点
13
主要终点
Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light

研究概览

简要总结

The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during laparoscopic cholecystectomy. The aim is to demonstrate that NIFC performs better than standard white light (WLI) alone in visualizing and identifying extra-hepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before and after dissection during Laparoscopic Cholecystectomy (LC).

详细描述

Recently, a novel technique to visualize structures using fluorescent light and intravenous dye has been developed.

Near Infrared Incisionless Fluorescent Cholangiography (NIFC) is a medical imaging technique that uses fluorescence to detect properly labeled structures during surgery.

NIFC is performed using imaging devices with the purpose of providing real-time simultaneous information from color reflectance images (white light) and fluorescence emission (near infrared light). One or more light sources are used to excite and illuminate the sample. Light is collected using optical filters that match the emission spectrum of the fluorophore. Imaging lenses and digital cameras are used to produce the final image.

During laparoscopic cholecystectomies, the visualization of the extra-hepatic bile ducts with fluorescence is called Near Infrared Incisionless Fluorescent Cholangiography (NIFC). Fluorescence equipment and a dye are necessary in order to perform a NIFC, but the technique requires no radiation or incision. A fluorescence dye is administrated intravenously at least 45 minutes before the surgery, which is excreted by the liver and the bile duct The Study is designed to compare the effectiveness of Near Infrared Fluorescence Cholangiography (NIFC) to standard white light imaging (WLI) in visualizing and identifying the main biliary and hepatic structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction and any Accessory Ducts) during laparoscopic cholecystectomy.

Eligible patients will be identified through clinical and test evaluation. Eligibility will be verified by the patient's primary surgeon. The surgeon will determine the indication and date of the surgery. Once a patient is confirmed as eligible, the surgeon will introduce the study in detail. If after being introduced to the study and having had the opportunity to ask questions, the patient is willing to participate, he/she will be asked to review and sign the informed consent document .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders
  • Minimum age: 18 years old
  • Spoken and written command of the language spoken in the country's center
  • Ability to understand and follow the study procedures and sign the informed consent

排除标准

  • Known allergies to iodides
  • Known history of coagulopathy
  • Known moderate or severe liver disease Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out

研究组 & 干预措施

Xenon Light

Active Comparator

Laparoscopic cholecystectomy with Xenon Light

干预措施: Laparoscopic cholecystectomy with Xenon light (Procedure)

Near infrared light

Experimental

Laparoscopic cholecystectomy with Near infrared light

干预措施: Laparoscopic cholecystectomy with Xenon light (Procedure)

Near infrared light

Experimental

Laparoscopic cholecystectomy with Near infrared light

干预措施: Laparoscopic cholecystectomy (fluorescent cholangiography) (Procedure)

结局指标

主要结局

Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light

时间窗: Immediately before dissection (baseline) and immediately after dissection during the same surgical procedure.

Detection rate of the common bile duct during laparoscopic cholecystectomy, defined as the proportion of patients in whom the common bile duct was visualized immediately before dissection (baseline) and immediately after dissection using near infrared light. The detection rate was calculated separately for each arm and reported as the percentage of patients with successful identification.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emanuele LoMenzo

Principal Investigator

The Cleveland Clinic

研究点 (13)

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