MedTrace Logo

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

NCT05419947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-06-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Laparoscopic Cholecystectomy

Interventions

DRUG

VERDYE powder for solution for injection 25 mg

Verdye 25 mg contains sodium VI powder for solution for injection. VI is a water-soluble agent with a spectral absorption peak of 800 nm. It is a drug approved for diagnostic use only and is indicated for the measurement of the excretory function of the liver.

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Jaime López Sánchez, MD · University of Salamanca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-20
Primary Completion
2023-05-16
Completion
2023-10-24

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05419947 on ClinicalTrials.gov