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Clinical Trials/NCT04908826
NCT04908826UnknownNot Applicable

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

Aristotle University Of Thessaloniki2 sites in 1 country240 target enrollmentStarted: January 3, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
240
Locations
2
Primary Endpoint
applicability of the intra-operatively cholangiography

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

applicability of the intra-operatively cholangiography

Time Frame: intra-operatively

yes or no

presence of bile duct stones (choledocholithiasis)

Time Frame: intra-operatively

yes or no

successful imaging of biliary system

Time Frame: 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.

operation duration

Time Frame: intra-operatively

minutes

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

Time Frame: intra-operatively

presence or absence

Secondary Outcomes

  • ALP(24 hours prior to surgery and 24 hours after the surgery)
  • gender(pre-operatively)
  • total bilirubin(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)
  • 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)
  • urea(24 hours prior to surgery and 24 hours after the surgery)
  • aPTT(24 hours prior to surgery and 24 hours after the surgery)
  • body mass index(pre-operatively)
  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Savvas Simeonidis

Principal Investigator

Aristotle University Of Thessaloniki

Study Sites (2)

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