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

NCT06629415 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: PT (657)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

common bile duct injury, Intracholecystic, fluorescence cholangiography, indocyanine green, laparoscopic cholecystectomy.

Outcome Measures

Primary Outcomes (1)

• The rate of better delineation of the biliary tree during laparoscopic cholecystectomy

  To detect the safety, efficacy, feasibility and accuracy in defining the biliary anatomy during laparoscopic cholecystectomy.

  intraoperative and 2 weeks postoperative

Study Arms (2)

Intravenous Injection Injection of Indocyanine Green (ICG)

ACTIVE COMPARATOR

7.5 mg (3 ml of a 25 mg/10 ml solution) of indocyanine green was injected intravenously in the pre-operative holding area at least 20 minutes before surgery to outline the biliary tree during laparoscopic cholecystectomy.

Drug: Indocyanine Green

Transhepatic intracholecystic injection of Indocyanine Green (ICG)

ACTIVE COMPARATOR

Intracholecystic injection of ICG was done in 30 patients. Twenty 1.25 mg particles, one from a 25 mg ICG vial, were separated under aseptic conditions.

Drug: Indocyanine Green Drug

Interventions

Indocyanine Green DRUG

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

Intravenous Injection Injection of Indocyanine Green (ICG)

Indocyanine Green Drug 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.

Transhepatic intracholecystic injection of Indocyanine Green (ICG)

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of gall bladder pathology (cholecystitis, gall bladder polyp) Patients fit for laparoscopic cholecystectomy.

You may not qualify if:

• Patients with contraindication for laparoscopic cholecystectomy (for example patients had significant pulmonary or cardiac problems or severe renal insufficiency).
• Proven or suspected allergies to ICG. pregnancy or lactation.

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Egypt

Location

Related Publications (1)

• van Manen L, Handgraaf HJM, Diana M, Dijkstra J, Ishizawa T, Vahrmeijer AL, Mieog JSD. A practical guide for the use of indocyanine green and methylene blue in fluorescence-guided abdominal surgery. J Surg Oncol. 2018 Aug;118(2):283-300. doi: 10.1002/jso.25105. Epub 2018 Jun 24.

  PMID: 29938401 BACKGROUND

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: May 5, 2022
• Primary Completion: May 10, 2023
• Study Completion: May 10, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)