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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Collaborator: Instituto de Investigación Biomédica de Salamanca

Criteria

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.