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临床试验/NCT03024892
NCT03024892Unknown不适用

Intra-gallbladder or Systemic Indocyanide Green Injection Facilitate Cholecystectomy in Acute Cholecystitis , Gallstone and Gallbladder Polyp Patients.

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
600
试验地点
2
主要终点
CHD identification ( white light and infrared fluroscence image)

研究概览

简要总结

The investigators will collect the pre-operative medical history and arrange physical examination, life quality evaluation, blood and biochemical test. The Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study. Four laparoscopic ports were introduced and the pneumoperitoneum (12mmHg) was established. In study group , ICG was give by intra-gallbladder injection or systemic injection, the cholecystectomy were performed . In control group, no ICG was given and traditional cholecystectomy were performed. A near-infrared optimized laparoscope was used to detect the ICG fluorescence signal arising from gallbladder , cystic duct and common bile duct before cholecystectomy in study group. According to the enhancement of ICG, the cholecystectomy was started from cystic duct in Calot's triangle.Time to gallbladder removed was recorded. Conversion rate, post-operative morbidity and mortality will be recorded as well .

详细描述

Back Ground:

Laparoscopic cholecystectomy(LC) is the one of most common procedure done by minimal invasive surgery worldwide but the common bile duct(CBD) injury still happened even the existence of standard technique with growing experience and new technology, especial in cholecystitis. Image guided surgery created new concept for fluorescent cholangiography to demonstrate the anatomy of CBD by using indocyanine green (ICG) intravenous injection before operation to decreased complication. The result is positive but the border of gallbladder can't be seen very well in systemic injection . In cholecystitis, the border between gallbladder and common bile duct is important as well as CBD and cystic duct.

Purpose:

The investigators hypothesized injection of ICG into gallbladder directly will be helpful to identify cystic duct, CBD and the border of gallbladder as well as systemic injection . The purpose of this study was to evaluate feasibility of this image guide surgery

Study Design:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute cholecytitis, gallstone or gallbladder polyp without interventional treatment or cholecystitis after percurtaneus gallbladder drainage(PTGBD) were involved in this study.

排除标准

  • a.Pregnancy and Breast feeding female.
  • b.Patients have another severe medical diseases.(ex: heart failure, respiratory failure and stroke etc.)
  • c.Not suitable for patients receiving anesthesia.
  • d.Alcoholism, drug abuse and psychopaths.
  • e.Iodine allergies and renal failure patients.

研究组 & 干预措施

ICG gallbladder

Experimental

patients who received ICG injection via gallbladder and received fluroscence image guided surgery

干预措施: ICG GB (Procedure)

ICG IV

Experimental

patients who received ICG injection via peripheral vein and received fluroscence image guided surgery

干预措施: ICG IV (Procedure)

LC conventional

Sham Comparator

Patients received conventional laparoscopic cholecystectomy

干预措施: LC conventional (Procedure)

LC conventional and IOC

Sham Comparator

Patients received conventional laparoscopic cholecystectomy + intraoperative cholangiography

干预措施: LC conventional and IOC (Procedure)

结局指标

主要结局

CHD identification ( white light and infrared fluroscence image)

时间窗: intra-operative period

evaluation rate the visualization of Hartmann's pouch between two method

conversion rate

时间窗: intra-operative period

the rate for calculate the conversion from laparoscopic cholecystectomy to open cholecystectomy

Hartmann's pouch identification ( white light and infrared fluroscence image)

时间窗: intra-operative period

evaluation rate the visualization of Hartmann's pouch between two method

Cystic duct identification ( white light and infrared fluroscence image)

时间窗: intra-operative period

evaluation rate the visualization of Hartmann's pouch between two method

CBD identification ( white light and infrared fluroscence image)

时间窗: intra-operative period

evaluation rate the visualization of Hartmann's pouch between two method

次要结局

  • Post op morbidity(Post op day 7)
  • CBD injury(post op day 3)
  • Post op mortality(Post op day 30)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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