跳至主要内容
临床试验/NCT04908826
NCT04908826Unknown不适用

Comparison of Administration of Indocyanine Green (ICG) for Image-Guided Laparoscopic Cholocystectomy- A Randomized, Controlled, Prospective Trial

Aristotle University Of Thessaloniki1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
240
试验地点
1
主要终点
applicability of the intra-operatively cholangiography

研究概览

简要总结

The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.

详细描述

Laparoscopic cholecystectomy is now the method of choice for the treatment of symptomatic and complicated gallstones.

There are two major problems that can occur during and after a laparoscopic cholecystectomy. These are the remaining stones in the bile duct and the iatrogenic injuries of the bile ducts. Iatrogenic bile duct injuries are the most difficult complication of cholecystectomy and are a clinical entity that needs multifactorial treatment as it significantly increases morbidity, mortality and overall cost. Intraoperative cholangiography is used to prevent these complications.

Intraoperative cholangiography is the traditional method of identifying bile duct anatomy during laparoscopic cholecystectomy. This method has the disadvantages that both the patient and the staff are exposed to radiation, while in order to perform it, catheterization of the cystic duct must be performed, which requires surgical procedures that increase the time of the operation, while in some cases it is not technically easy. Finally, with the intraoperative cholangiography, the injuries of the bile ducts are detected, after they have taken place, therefore it helps in their timely diagnosis but does not limit the frequency of their occurrence.

Indocyanine green is a sterile, anionic, water-soluble but relatively hydrophobic tricarbocyanine molecule with a molecular weight of 751.4. It was developed in 1955 at Kodak Laboratories and in 1959 was approved for clinical use by the FDA. It has the property of fluorescing, after its administration, with a maximum absorption at 800 nm after exposure to infrared lighting. Its use offers an image of high clarity and sensitivity, target imaging, with parallel low acoustic emission. Indocyanine green has the following properties and advantages, which make it an important tool in the applications of medical sciences and studies.

Following intravenous administration, it binds to plasma lipoproteins with minimal escape into the interstitial space. Extremely important for its clinical use is the complete excretion through the bile, as well as the non-production of metabolic products. It has low toxicity in the absence of ionization, which in combination with the short half-life of the substance, provides safety for the patient in its use and application in medical and biomedical sciences. It has low costs that in combination with its ease of use facilitates its application. No expensive equipment or large learning curve required. Also the possibility of recurrence with re-administration intraoperatively can offer a number of applications in laparoscopic surgery. It has a low rate of side effects and interactions with other drugs and preparations, a major allergic reaction has been reported in the literature. The first clinical applications of indocyanine green were to assess cardiac function, liver function in cirrhotic patients before hepatectomy, and to examine the retinal vessels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age older than 18 years old
  • •laparoscopic cholecystectomy
  • •elective surgery

排除标准

  • •younger than 18 years old
  • •no consent to participate to the study
  • •history of allergic reaction to iodine products
  • •urgent or emergent cholecystectomy

研究组 & 干预措施

Group A (standard cholangiography during surgery)

Active Comparator

All patients will undergo laparoscopic cholecystectomy. In this group standard cholangiography will be performed during surgery. Standard cholangiography will be performed with selective catheterization of the cystic duct and infusion of a radiolucent substance (non-ionic low osmotic iodine). The category includes drugs such as iohexol, iopamidol, iopromide, ioversol, iobitriol, iomeprol and iodixanol. In our study we will use Xenetix (iobitriol) and perform cholangiography with C-ARM recording.

干预措施: Indocyanine Green (ICG) administration (Procedure)

Group B (cholangiography with iv administration of icg prior to surgery)

Active Comparator

All patients will undergo laparoscopic cholecystectomy. In this group intravenous fluorescent cholangiography with indocyanine green will be given at a dose of 0.3 mg / mL / Kg 6 (six) hours before the start of surgery.The bile duct system will be recorded with a special camera (Karl Storz NIR / ICG).

干预措施: Indocyanine Green (ICG) administration (Procedure)

Group C (cholangiography with direct administration of icg to the bile duct system during surgery)

Active Comparator

All patients will undergo laparoscopic cholecystectomy. In the third group intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the bile duct cyst.

干预措施: Indocyanine Green (ICG) administration (Procedure)

结局指标

主要结局

applicability of the intra-operatively cholangiography

时间窗: intra-operatively

yes or no

presence of bile duct stones (choledocholithiasis)

时间窗: intra-operatively

yes or no

operation duration

时间窗: intra-operatively

minutes

successful imaging of biliary system

时间窗: intra-operatively

The anatomy of the extrahepatic bile ducts will be orally determined by the surgeon and the cases in which the oral description will coincide with the findings of cholangiography or not and where there were differences will be recorded.

intra-operative complications (bleeding, bile duct leakage, bile duct injury)

时间窗: intra-operatively

presence or absence

次要结局

  • total bilirubin(24 hours prior to surgery and 24 hours after the surgery)
  • ALP(24 hours prior to surgery and 24 hours after the surgery)
  • SGPT(24 hours prior to surgery and 24 hours after the surgery)
  • γ-GT(24 hours prior to surgery and 24 hours after the surgery)
  • indirect bilirubin(24 hours prior to surgery and 24 hours after the surgery)
  • WBC(24 hours prior to surgery and 24 hours after the surgery)
  • gender(pre-operatively)
  • ASA score(pre-operatively)
  • age(pre-operatively)
  • indication for laparoscopic cholecystectomy(pre-operatively)
  • SGOT(24 hours prior to surgery and 24 hours after the surgery)
  • direct bilirubin(24 hours prior to surgery and 24 hours after the surgery)
  • INR(24 hours prior to surgery and 24 hours after the surgery)
  • body mass index(pre-operatively)
  • aPTT(24 hours prior to surgery and 24 hours after the surgery)
  • creatinine(24 hours prior to surgery and 24 hours after the surgery)
  • PT(24 hours prior to surgery and 24 hours after the surgery)
  • TNF-a(24 hours prior to surgery and 24 hours after the surgery)
  • urea(24 hours prior to surgery and 24 hours after the surgery)
  • CRP(24 hours prior to surgery and 24 hours after the surgery)
  • procalcitonin(24 hours prior to surgery and 24 hours after the surgery)
  • IL-6(24 hours prior to surgery and 24 hours after the surgery)
  • ESR(24 hours prior to surgery and 24 hours after the surgery)

研究者

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

Savvas Simeonidis

Principal Investigator

Aristotle University Of Thessaloniki

研究点 (1)

Loading locations...

相似试验