Near-infrared Fluorescence Cholangiography Assisted Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy (FALCON): a Multicenter Randomized Controlled Trial

Laparoscopic cholecystectomy (LC) is one of the most commonly performed laparoscopic procedures in gastrointestinal surgery. Bile duct injury during this procedure is rare but constitutes a serious complication (0.3-0.7%) (Flum 2003, Fletcher 1999, Nuzzo 2005 and Waage 2005). Misidentification of the extra-hepatic bile duct anatomy during laparoscopic cholecystectomy is the main cause of bile duct injury (Way 2006).

The Critical View of Safety (CVS) technique, which was first described by Strasberg in 1995 (Strasberg 2003) and recommended by the Dutch Guidelines and Best Practice for laparoscopic cholecystectomy (Lange 2006), was introduced to reduce the risk of bile duct injury. To establish CVS, two windows need to be created: one window between the cystic artery, cystic duct and gallbladder, another window between the cystic artery, gallbladder and liver. The CVS technique is especially aimed at mobilizing the gallbladder neck from the liver, in order to obtain a circumferential identification of the transition of the cystic duct into the gallbladder.

Intraoperative cholangiography has been advised to reduce the risk of bile duct injury (Flum 2003, Buddinhg 2011). However, this radiological imaging of the biliary tree is only used selectively, as the process takes time, radiation exposure is involved and additional equipment and manpower for the procedure are required. Therefore, worldwide consensus about implementation of intraoperative cholangiography is still lacking (Ford 2012).

Near-infrared fluorescence (NIRF) imaging after intravenous injection of indocyanine green (ICG) is a promising new technique for easier intraoperative recognition of the biliary anatomy. It may help improve the outcome of laparoscopic cholecystectomy (Buddingh 2011, Agarwal 2009). ICG is cleared quickly and exclusively by the liver after intravenous administration. Neither radiological support nor additional intervention, such as opening the biliary tree, is required. The NIRF laparoscopy technique using ICG has been evaluated in various animal models (Figueiredo 2010, Figueiredo 2011, Tagaya 2010, Matsui 2010) and in open, laparoscopic, and single-incision laparoscopic cholecystectomy (Tagaya 2010, Ishazawa 2010, Ishazawa 2011 Aoki 2010). Promising results were presented for successful intraoperative identification of the common bile duct and the cystic duct, compared to conventional laparoscopic imaging. Another clinical study showed that the NIRFC technique provides significantly earlier identification of the extra-hepatic bile ducts during the CVS dissection phase: up to 10 minutes earlier identification of cystic duct and common bile duct could be obtained (Schols 2012). Real-time simultaneous imaging of the hepatic and cystic arteries can also be obtained (Ashitate 2011, Mitsuhashi 2008, Schols 2013).

Despite the encouraging results from these (pre)clinical feasibility studies, wide clinical acceptance of the routine use of ICG fluorescence laparoscopy is still lacking due to the absence of reliable clinical data. Therefore, a multicenter randomized clinical study is desirable to assess the potential added value of the fluorescence imaging technique during laparoscopic cholecystectomy in order to perform a more safe procedure leading to a reduction in the vascular and bile duct injuries. This study will compare NIRF assisted laparoscopic cholecystectomy to conventional laparoscopic cholecystectomy.