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Using Indocyanine Green (ICG) to Outline Biliary Tree During Laparoscopic Cholecystectomy

NCT06629415 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-08

No results posted yet for this study

Summary

The current study shows that Indocyanine green (ICG)-fluorescence cholangiography can be useful in identifying the extrahepatic biliary anatomy during Calot's triangle dissection. By avoiding hepatic fluorescence, the transhepatic intracholecystic-ICG route can increase the bile duct-to-liver contrast with less expense and no risk of hypersensitivity reactions than the intravenous ICG injection method. We recommend to use both techniques in case of acute cholecystitis with cystic duct obstruction. In cases of liver cirrhosis, we recommend transhepatic IC-ICG as IV-ICG is limited.

Conditions

  • Chronic Calculous Cholecystitis
  • Laparoscopic Cholecystectomy

Interventions

DRUG

Indocyanine Green

injecting 7.5 mg (3 ml of a 25 mg/10 ml solution) intravenously in the pre-operative holding area at least 20 minutes before surgery. Before dissecting the adhesions surrounding the hepatoduodenal ligament, fluorescence cholangiography (FC) is carried out to determine the anatomy of the extrahepatic bile ducts by converting the full-color images to fluorescence images using filter switches on the camera head and/or light source in the laparoscopic imaging system (Fig. 1). The \"critical view of safety\" is then reached by dissecting Calot\'s triangle and using FC to verify whether the accessory bile ducts are present or absent throughout the procedures. It is necessary to acquire fluorescence image

DRUG

Indocyanine Green Drug

1.25 mg of ICG powder was dissolved in 3 cm of saline, and the concentration was roughly 0.04 mg after each 1 cm of saline was diluted by 9 cm of saline. In order to prevent dye leakage that might result in false FC results, a veress needle was inserted through the abdominal wall and into the gall bladder fundus through the liver bed. The puncture site was then cauterized.

Sponsors & Collaborators

  • Theodor Bilharz Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2023-05-10
Completion
2024-05-10
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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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 NCT06629415 on ClinicalTrials.gov