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

Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy

Laparoscopic; Cholecystectomy

Cholelithiasis; Bile Duct

Choledocholithiasis

Stone - Biliary

Post-Op Complication

Cholangiography

Indocyanine Green

Intraoperative Complications

Bile Duct Injury

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.

      Its use in laparoscopic cholecystectomy, as already mentioned, is based on its ability to
      fluoresce when exposed to infrared light and in combination with the fact that when
      administered intravenously it is concentrated and excreted from the bile offers the
      possibility of intraoperative, fluorescent cholangiography that aims to identify the elements
      of the Callot triangle.

      This study aims to demonstrate that endocyanin green cholangiography is equivalent to or
      better than conventional cholangiography for the diagnosis of cholelithiasis and biliary
      injuries. It is therefore an important clinical application that will probably facilitate
      surgeons both in the prevention of biliary injuries and in the intraoperative diagnosis of
      cholelithiasis.

      Patients who will undergo laparoscopic cholecystectomy will be randomly divided into 3
      (three) groups. The processing of the results will be done in the appropriate way and method.
      A total of 240 patients will be randomized into three groups of 80. In the first group (A)
      classical cholangiography will be performed. In group (B) will be performed intravenous
      fluorescent cholangiography with indocyanine green 6 (six) hours before the start of surgery.
      In the third group (C) will be performed intraoperative cholangiography with direct
      administration of indocyanine green to the gallbladder.

Indocyanine Green (ICG) administration

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

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.

Principal Investigator

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.

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).

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.

Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status