Onderzoek naar het met een fluorescerende stof zichtbaar maken van de galwegen tijdens operatie voor het verwijderen van de galblaas in patiënten met gecompliceerd galsteenlijden

Injuries to the CBD are rare but serious complications with need for re-intervention, risk of permanent disability and prolonged hospital stay. Patients at risk for bile duct injury are those suffering from acute cholecystitis, biliary pancreatitis, bleeding, scarred or shrunken gallbladder due to previous infection, gallstones in Hartmann’s pouch, a short cystic duct, Mirizzi’s syndrome and abnormal biliary anatomy. With fluorescent imaging of the bile ducts during surgery, using Indocyanine green and a near-infrared camera, good results are reported in patients undergoing laparoscopic cholecystectomy with symptomatic gall stones. In patients at higher risk for per-operative bile duct injury, as defined by the inclusion criteria of this clinical trial, intra-operative cholangiogram is performed in order to visualize the bile ducts during surgery.



Methods:

Patients eligible for laparoscopic cholecystectomy in the setting of complicated gallbladder disease are included in the study. An intravenous injection of ICG is administered before induction of general anesthesia. During standard laparoscopic cholecystectomy, the near-infrared camera is used to visualize the biliary structures. At set times during surgery, identification of the bile ducts with the near-infrared and the conventional camera is done and scored by the investigator. Post-operative care is conform standard surgical procedures.

Peroperative fluorescent imaging of the bile ducts will improve visibility and results in early identification of the common bile duct and the cystic duct during laparoscopic cholecystectomy in patients at risk for bile duct injury.

Per-operative: ICG-NIR vs conventional identification of bile ducts:

1. Before start of dissection

2. At Critical view of Safety
additionally: Early and late during dissection, before CVS is obtained

Pre-operative patients receive 1 dosis of Indocyanine Green (ICG), which is a fluorescent contrast agent that is excreted by the liver into the bile. Per-operative a near-infrared laparoscopic camera is used to visualize the ICG in the bile ducts. During the laparoscopic cholecystectomy, both the conventional and near-infrared camera will be used to identify the common bile duct and cystic duct.