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Comparison of Icg's Route of Administration During Laparoscopic Cholecystectomy

NCT04908826 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2022-03-10

No results posted yet for this study

Summary

The aim of the trial is to compare the routes of administration of indocyanine green (ICG) during laparoscopic cholocystectomy.

Conditions

  • Laparoscopic; Cholecystectomy
  • Cholelithiasis; Bile Duct
  • Choledocholithiasis
  • Stone - Biliary
  • Post-Op Complication
  • Cholangiography
  • Indocyanine Green
  • Intraoperative Complications
  • Bile Duct Injury

Interventions

PROCEDURE

Indocyanine Green (ICG) administration

Patients will undergo laparoscopic cholecystectomy after they are randomly divided into 3 (three) groups. A total of 240 patients will be randomized into three groups of 80. In the first group (A) standard cholangiography will be performed. In group (B) intravenous fluorescent cholangiography with indocyanine green will be performed during surgery. ICG at a dose of 0.3 mg / mL / Kg 6 (six) hours prior to surgery will be administered. In the third group (C), intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the gallbladder.

Sponsors & Collaborators

  • George Papanicolaou Hospital

    collaborator OTHER

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Savvas Simeonidis, MD, PhD(c) · General Hospital of Thessaloniki "G. Papanikolaou", Aristotle University of Thessaloniki

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2022-06-01
Completion
2023-01-01

Countries

  • Greece

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 NCT04908826 on ClinicalTrials.gov