Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy. (DOTIG)

  • STATUS
    Recruiting
  • End date
    Dec 21, 2023
  • participants needed
    200
  • sponsor
    Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Updated on 4 October 2022

Summary

Laparoscopic cholecystectomy is one of the most performed surgical procedures worldwide. One of its most serious complications is injury to the main bile duct, with an incidence of less than 1%. There are different surgical strategies that try to reduce this complication, with indocyanine green fluorescence cholangiography being one of the most recent to appear. This technique is becoming a great tool during laparoscopic cholecystectomy. Despite the great rise of the procedure, today there is a great disparity in the administration protocols of indocyanine green during the procedure.

Goals. The main objective of the study is to analyze whether there are differences between different types of doses and administration intervals of indocyanine green to obtain quality fluorescent cholangiography during laparoscopic cholecystectomy. In addition, the factors that influence the results of the technique will be sought.

Description

Symptomatic cholelithiasis is a pathology of great relevance in the world population, with prevalence rates of up to 20%. The standard treatment for cholelithiasis is laparoscopic cholecystectomy (LC). One of the most serious complications of LC is injury to the main bile duct (LVB). Although this complication has incidences of less than 1% (0.3-0.7% in the different series), the consequences it causes are highly relevant. LVB is related to a significant increase in patient morbidity and mortality, a significant deterioration in quality of life, a very significant increase in healthcare costs and not insignificant medical-legal consequences. Indocyanine green fluorescence cholangiography (CF-VI) is a novel technique that allows precise and real-time anatomical visualization of the extrahepatic biliary anatomy, facilitating surgery and reducing the risk of complications. Currently, there are large differences in LV administration protocols during CF in LC. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization. In relation to the dose, there are many protocols for IV administration, by means of a single dose or a dose adjusted for the patient's body weight. Some authors advocate the administration of IV 24 hours before the procedure, in order to avoid hepatic fluorescence. However, in the context of major outpatient surgery, outpatient surgery or short-stay surgery, we believe that this practice is not currently logistically feasible. Other groups administer the IV with a variable range of time interval. The recent preliminary results of the European Registry of Fluorescent Image Guided Surgery show the great disparity of preoperative LV administration protocols. Therefore, it is necessary to protocolize the administration of the drug based on the results of randomized clinical trials.. The precise dose and the ideal moment of administration are key to achieving adequate visualization of the critical vascular and biliary structures and to reduce the fluorescence emitted by the hepatic parenchyma, which could hinder correct anatomical visualization.

Details
Condition Laparoscopic Cholecystectomy
Treatment VERDYE powder for solution for injection 25 mg
Clinical Study IdentifierNCT05419947
SponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age over 18 years
Autonomy, self-sufficiency and independence
Scheduled CL indication
Symptomatic cholelithiasis: history of biliary colic, acute lithiasic cholecystitis, choledocholithiasis, acute ascending cholangitis of lithiasic origin or acute lithiasic pancreatitis
Gallbladder polyps with indication for laparoscopic surgery
Vesicular adenomyomatosis with indication for laparoscopic surgery
Indication of early LC (<72 hours of admission for acute stone cholecystitis/acute acalculous cholecystitis/complicated biliary colic)
Deferred urgency LC indication
Understanding of information
Signature of the informed consent

Exclusion Criteria

Age less than 18 years
Disability
Pregnancy or lactation
Chronic kidney disease (Stage > IIIb)
Previous adverse reactions or allergies to VI
Previous adverse reactions or allergies to VI excipients
Adverse reactions or confirmed allergies to iodinated contrast agents
Functional thyroid pathology (hyperthyroidism, thyroiditis, toxic multinodular goiter, functioning thyroid adenoma)
Urgent non-deferrable/emergent gallbladder surgery
Initial surgery by laparotomy
Previous suspicion of gallbladder carcinoma
Inability to understand the information needed to participate in the study
Rejection of inclusion within the study protocol
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