Comparison of Administration of Indocyanine Green (ICG) for Image-Guided Laparoscopic Cholocystectomy- A Randomized, Controlled, Prospective Trial
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)
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)
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)
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
Savvas Simeonidis
Principal Investigator
Aristotle University Of Thessaloniki
