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

Phase 4

Completed

Conditions: Laparoscopic Cholecystectomy

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

Registration Number: NCT05419947

Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Brief 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed dose 3 hours	VERDYE powder for solution for injection 25 mg	Fixed dose 2.5 mg with IV administration at a time greater than 3 hours before surgery.
Fixed dose 30 min	VERDYE powder for solution for injection 25 mg	Fixed dose 2.5 mg with IV administration during the immediate preoperative period (15-30 minutes before surgery).
Weight-adjusted dose 30 min	VERDYE powder for solution for injection 25 mg	Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration during the immediate preoperative period (15-30 minutes before surgery).
Weight-adjusted dose 3 hour	VERDYE powder for solution for injection 25 mg	Weight-adjusted dose (0.05 mg/kg of total body weight) with IV administration greater than 3 hours before surgery.

Primary Outcome Measures

Name	Time	Method
Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.	During surgical procedure, before beginning the dissection of the hepatocystic triangle.	Identification of biliary structures prior to dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection
Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.	During surgical procedure, after dissection of the hepatocystic triangle.	Identification of biliary structures after dissection of the hepatocystic triangle. Participants may be assigned to multiple categories according to the intraoperative identification of distinct anatomical structures observed in each case. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once disection of the hepatocystic triangle has begun. Category 1. Identification of the cystic duct prior to dissection Category 2. Identification of the common bile duct prior to dissection Category 3. Identification of the junction of the cystic duct with the common bile duct prior to dissection Category 4. Identification of the union of the cystic duct with the gallbladder prior to dissection Category 5. Identification of the common hepatic duct prior to dissection Category 6. Identification of biliary anatomical variables prior to dissection

Secondary Outcome Measures

Name	Time	Method
Degree of Identification of Biliary Structures Prior to Dissection of the Hepatocystic Triangle.	During surgical procedure, before beginning the dissection of the hepatocystic triangle.	Degree of identification of biliary structures prior to dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the surgery has begun, but before the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Degree of Identification of Biliary Structures After Dissection of the Hepatocystic Triangle.	During surgical procedure, after the disection of the hepatocystic triangle has begun.	Degree of identification of biliary structures after dissection of the hepatocystic triangle. The fluorescent green substance, VERDYE, will be injected to the patients in order to visualize the below listed organs once the disection of the hepatocystic triangle has begun. The following scale will be used: 1=little, 2=sufficient, 3=quite a bit, 4=good, 5=excellent. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Extent to Which Fluorescence Cholangiography Was Perceived as Useful for Surgery	During surgical procedure	Extent to which fluorescence cholangiography was perceived as useful for surgery. Participants were assigned toeach category according to the intraoperative identification of distinct anatomical structures observed in each case,once the surgery has begun. The following scale will be used: 0=not useful, 1=moderately useful, 2=very useful. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.
Extent to Which Liver Fundus Fluorescence (Contrast Between Liver and Ducts) Was Perceived as Disturbing.	During surgical procedure	Extent to which liver fundus fluorescence (contrast between liver and ducts) was perceived as disturbing. Participants were assigned to each category according to the intraoperative identification of distinct anatomical structures observed in each case, once the surgery has begun. The following scale will be used: 0=no disturbance, 1=slightly disturbed, 2=disturbed visualization, but cystic-bile duct junction was clearly visible before dissection, 3=disturbed visualization and cystic-bile duct junction was only visible after dissection. dissection and 4= very disturbed: it was impossible to correctly visualize the biliary structures. It is scale based on the observation of the surgeon, not an international surgical scale. Hence, it does not have a specific name.

Trial Locations

Locations (2): Hospital Universitario Germans Trias i Pujol.
🇪🇸
Badalona, Barcelona, Spain
Complejo Asistencial Universitario de Salamanca
🇪🇸
Salamanca, Spain
Hospital Universitario Germans Trias i Pujol.
🇪🇸Badalona, Barcelona, Spain