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

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Status and phase: Completed; Phase 4

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: VERDYE powder for solution for injection 25 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05419947

IBS-DOTIG-ECM-2202

2022-000904-36 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Fixed dose 3 hours

Experimental group

Description:

Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.

Treatment:

Drug: VERDYE powder for solution for injection 25 mg

Fixed dose 30 min

Experimental group

Description:

Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).

Treatment:

Drug: VERDYE powder for solution for injection 25 mg

Weight-adjusted dose 3 hour

Experimental group

Description:

Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.

Treatment:

Drug: VERDYE powder for solution for injection 25 mg

Weight-adjusted dose 30 min

Experimental group

Description:

Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).

Treatment:

Drug: VERDYE powder for solution for injection 25 mg