The Bile Duct Injury (BDI) rate with laparoscopic cholecystectomy is reported to be 0.5%1, and while relatively low, when injuries occur, they can be catastrophic.2
Use of IC-Green® Injection (ICG) in Minimally Invasive Surgery
Minimally Invasive Surgery (MIS), using small incisions to minimize trauma to normal tissues and adjacent organs, is now the preferred method of undertaking many surgeries.
The global minimally invasive surgical systems market is expected to grow at a CAGR of 10.9% from 2020 to 2025, driven by the rapidly increasing demand from the patients undergoing minimally invasive surgical procedures, increasing surgical need, and the surge in the prevalence of colorectal and other gastrointestinal diseases.1
New technological advancements, such as miniaturization of surgical equipment and development of surgical robots, have substantially increased the number of minimally invasive surgeries performed across the world.
Laparoscopic Cholecystectomy (Lap Chole)
Key Features
Laparoscopic Cholecystectomy is the gold standard for gall bladder surgery and is one of the most common surgeries undertaken worldwide. In the USA an estimated one million Lap Chole’s are undertaken each year, with an estimated 500,000 in Europe.2 Whilst the incidence of Bile Duct Injury (BDI) is low at 0.5%, due to the considerable amount of surgeries, this becomes quite a significant number with thousands of resultant patients per year thus sustaining BDI’s, with severe and long term implications for their health.2 The primary cause of error in 97% of Lap Chole cases was a visual perception illusion, which is one of the major drawbacks of an MIS approach.3</sup<
ICG fluorescence imaging during Laparoscopic Cholecystectomy (Lap Chole) surgery reduces BDI injuries and improves patient outcomes
The primary cause of error in 97% of cases was a visual perception illusion.3
Surgeons had a 3-fold improvement in ability to visualize critical bile duct structures using ICG.4
Profit margins at hospitals drop from 13% to 1% when complications in lap chole surgeries occur.5
ICG Guided Cholecystectomy vs X-Ray Cholangiography
X-Ray Cholangiography has been used in the past to overcome this visualization problem. However it has drawbacks that are not apparent with Indocyanine Green (ICG) use.
Colorectal Surgery
Colorectal surgery frequently involves bowel resection with restoration of the alimentary tract by anastomosis. Indocyanine green (ICG) fluorescence imaging has proven to be an effective tool to assess anastomotic perfusion. Its use for the prevention of anastomotic leaks (AL) has been gaining popularity, with accumulating data on lower leak rates with (ICG) fluorescence guided surgery.9
Most common methods used to evaluate the perfusion status of the colon has been to visually observe the change in colour of the colon wall with the surgeon’s naked eye and to carefully observe the pulse of the colon wall. However, these methods are subjective and not always accurate.
Reported rates of anastomotic leakage vary from 3-6% in experienced colorectal surgeons and 3-25% overall.10 Combining the use of ICG with a near-infra red (NIR) laparocsopic camera system offers the surgeon the possibility of an objective, real-time assessment of blood flow to the colon.
ICG Proven to reduce leak rates in Colorectal Surgery
There is a growing body of evidence that proves the significant value of using ICG in colorectal surgery.
Below is a summary of two recent Clinical Trials proving that ICG is safe, effective and is increasingly viewed as the gold standard in laparoscopic colorectal procedures.
ICG fluorescence imaging during Colorectal Surgery reduces the rate of leaks experienced by patients
Mortality rates associated with anastomotic leaks, range from 5-17%.15
Profit margins at hospitals drop by 8% when complications in colon surgeries occur.8
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use IC-Green® Injection safely and effectively. See full prescribing information for IC Green® Injection.
INDICATIONS AND USAGE
IC-Green® Injection (ICG) is a tricarbocyanine dye, is indicated for:
- Fluorescence imaging of vessels (micro- and macro-vasculature), blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures, in adults and pediatric patients aged 1 month and older
- Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients aged 12 years and older
- Fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer
- Ophthalmic angiography in adults and pediatric patients
DOSAGE AND ADMINISTRATION
Indicator-Dilution Studies.
Under sterile conditions, the IC-Green® Injection powder should be dissolved with the Sterile Water for Injection, USP provided and the solution used within 6 hours after it is prepared. The usual doses of IC-Green® Injection for dilution curves are: Adults 5.0 mg, Children – 2.5 mg, and Infants – 1.25 mg.
Hepatic Function Studies.
Under sterile conditions, the IC-Green® Injection powder should be dissolved with the Sterile Water for Injection, USP provided. The patient should be weighed and the dosage calculated on the basis of 0.5 mg/kg of body weight. Exactly 5 mL of Sterile Water for Injection, USP should be added to the 25 mg vial giving 5 mg of dye per mL of solution.
Ophthalmic Angiography Studies.
Dosages up to 40 mg IC-Green® Injection dye in 2 mL of Sterile Water for Injection, USP should be administered. A 5 mL bolus of normal saline should immediately follow the injection of the dye.
DOSAGE FORMS AND STRENGHTS
IC-Green® Injection is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide.
CONTRAINDICATIONS
IC-Green® Injection contains sodium iodide and should be used with caution in patients who have a history of allergy to iodides because of the risk of anaphylaxis.
WARNINGS AND PRECAUTIONS
- Deaths due to anaphylaxis have been reported following ICG administration during cardiac catheterization.
- IC Green® injection is unstable in aqueous solution and must be used within 6 hours
- Radioactive iodine uptake studies should not be performed for at least a week following the use of IC Green® injection.
ADVERSE REACTIONS
Most common adverse reactions are anaphylactic or urticarial reactions. These have been reported in patients with and without a history of allergy to iodides.
To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844- 424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@diagnosticgreen.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Products containing sodium bisulfite reduce the absorption peak of IC-Green® in blood.
All references available in the MIS brochure download
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