Status:
COMPLETED
Clinical Trial for the Optimization of Indocyanine Green Administration in NIRF-C During L.Cholecystectomy.
Lead Sponsor:
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Collaborating Sponsors:
Instituto de Investigación Biomédica de Salamanca
Conditions:
Laparoscopic Cholecystectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
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)...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05419947
Start Date
June 20 2022
End Date
October 24 2023
Last Update
June 17 2025
Active Locations (2)
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1
Hospital Universitario Germans Trias i Pujol.
Badalona, Barcelona, Spain, 08916
2
Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007