Cholecystocholangiography by Direct Intragallbladder Injection of ICG
Cholecystocholangiography by Direct Intragallbladder Injection of ICG
The objective of this clinical trial is to visualize the bile ducts by injecting a contrast
 that is only visible with infrared light. For this, a quantity of bile will be extracted from
 the gallbladder by puncture and the same amount of contrast will be introduced.

 During the intervention teh tissue wil be exposure to infrared light to visualize the bile
 ducts. This technique aims to increase safety in surgery to avoid damaging bile or vascular
 structures during gallbladder interventions.
Laparoscopic cholecystectomy is one of the most commonly performed procedures in adult
 surgery. A rare but serious complication of laparoscopic cholecystectomy is bile duct injury,
 with a reported incidence of 0.3-1.5 %. Bile duct injury is often caused by misinterpretation
 of the anatomical structures rather than by insufficient technical skills. Generally, bile
 duct injury leads to bile leakage, causing abdominal sepsis. It can also lead to obstruction,
 with obstructive jaundice, eventually potentially leading to a need for liver transplantation
 in the worst case. Late recognition is common in bile duct injuries, resulting in significant
 morbidity and mortality, a lower quality of life and extra costs. A recent expert consensus
 report identified establishment of the critical view of safety as the single most important
 factor for overall safety during laparoscopic cholecystectomy. However, evidence suggests
 that surgeons may actually achieve this view far less often than they believe.

 Numerous intraoperative visualization techniques and technologies have been developed to
 enhance the safety of laparoscopic cholecystectomy. There are mainly two intraoperative
 imaging techniques to consider: first, the historical X-ray-based intraoperative
 cholangiography, and secondly the emerging fluorescence-based intraoperative near-infrared
 cholangiography. Large retrospective and prospective studies have looked at the benefit of
 routine intraoperative radiographic cholangiography for detection of common bile duct stones
 and to identify or prevent bile duct injury. Whether this procedure should be performed
 routinely is still an active subject of debate as systematic reviews are inconclusive;
 however, several of the larger retrospective studies observed a decrease in frequency and
 severity of bile duct injury when intraoperative cholangiography is performed. Limiting
 factors for performing radiographic laparoscopic cholangiography include: it requires
 specific expertise in the technique and its interpretation; it involves the use of ionizing
 radiation; it is time-consuming; and it creates a risk for bile leakage and duct injury
 itself, since puncturing and cannulation of the cystic duct is required. These limitations
 justify the quest for alternative, less complicated techniques to visualize biliary anatomy
 during cholecystectomy. Fluorescence-based intraoperative near-infrared cholangiography
 during laparoscopic cholecystectomy has been introduced by Ishizawa et al. in recent years as
 a non-invasive, radiation-free, low-cost alternative for realtime visualization of the
 biliary anatomy. This technique requires near-infrared laparoscopic imaging systems, as well
 as the intravenous injection of a fluorophore, i.e., indocyanine green, which is eliminated
 through the biliary tree. Following exposure to the near-infrared fluorescenc light source,
 indocyanine green becomes fluorescent and highlights relevant biliary structures. Since the
 pioneer studies, a large number of trials have been conducted and several protocols are
 currently underway, in order to establish the clinical efficacy of near-infrared
 cholangiography. A recent systematic review of clinical studies on near-infrared
 cholangiography has reported high visualization rates of biliary structures, as a surrogate
 marker of clinical efficacy, before dissection of Calot's triangle. However, one of the most
 significant drawbacks of near-infrared cholangiography following systemic indocyanine green
 injection lies in the very high background signal due to the rapid accumulation of
 indocyanine green in the liver, which can impair the visualization of the biliary structures.

 One of the strategies to improve the visualization of the cystic duct and the common bile
 duct, without suffering from the disturbing background liver enhancement, is to perform a
 near-infrared cholecystocholangiography, by injecting the fluorophore directly into the
 gallbladder, as previously demonstrated in a porcine experimental study.
Inclusion Criteria:

 1. Scheduled for elective laparoscopic cholecystectomy.

 2. Normal liver and renal function.

 3. No hypersensitivity for iodine or indocianine green.

 4. Able to understand nature of the study procedures.

 5. Willing to participate and with written informed consent.

 Exclusion Criteria:

 1. Age < 18 years.

 2. Liver or renal insufficiency.

 3. Known iodine or indocianine green hypersensitivity.

 4. Pregnancy or breastfeeding.

 5. Not able to understand nature of the study procedure.