INtraoperative Approach With Eventual Clearance of Common bilE Duct by SpyGlass Discover vs Sequential Strategy in Patients With Acute Calculus Cholecystitis and Intermediate/High Risk of Common BiLE Duct Stone
INACCESSIBLE trial is a randomized controlled study that compares two different strategies for the treatment of Acute Calculous Cholecystitiis (ACC) patients with high/intermediate risk of CBDS, according to the score by Khoury T (named Israelian Score, IS). If a patient meets the inclusion and exclusion criteria, (s)he will be randomized to receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures (control group) or ELC + Spyglass cholangiography (study group). The follow-up will be performed after 30 days and 6 months from intervention with an outpatient medical examination
• have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
• have an Israelian Score (IS) for the risk of main bile duct stones of 2 or 3
• be \>18 years old
• onset of symptoms ≤7 days before Emergency Department (ED) admission
• provide signed and dated informed consent form
• be willing to comply with all study procedures and be available for the duration of the study.