Clinical trial to evaluate the dose and administration time of indocyanine green in fluorescent cholangiography during laparoscopic cholecystectomy.

Phase 1

• Conditions: aparoscopic cholecystectomy.; MedDRA version: 20.0Level: PTClassification code 10008611Term: CholecystectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2022-000904-36-ES
• Lead Sponsor: Instituto de Investigación Biomédica de Salamanca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-18
• Last Update Posted: 16 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 clinical trial of medicinal product
• Study Design: Not specified