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

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Apr 1, 2025

Keywords

ClinConnect Summary

The INACCESS trial is a study looking at two different treatment approaches for patients with Acute Calculous Cholecystitis (ACC), which is a condition caused by gallstones. The trial aims to compare a traditional method (involving two separate procedures: ERCP and Early Laparoscopic Cholecystectomy) with a new method that combines surgery with a special imaging technique called SpyGlass cholangiography. This is important because it helps doctors better manage patients who are at a higher risk of having stones in the common bile duct, which can cause serious complications.

To be eligible for this trial, participants need to be adults over 18 years old who have been diagnosed with ACC and whose symptoms started within the last week. They also need to have a specific score indicating a higher risk of bile duct stones. If someone chooses to participate, they will go through one of the two treatment methods and will have follow-up appointments 30 days and 6 months after their treatment to monitor their recovery. This study is currently recruiting participants and is designed to help improve the care of patients with this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • Pregnancy
• • Patients unwilling to undergo follow-up assessments
• • Patients diagnosed with concomitant cholangitis or pancreatitis
• • Acute cholecystitis not related to a gallstone etiology
• • Onset of symptoms \>7 days before ED admission
• • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
• • Biliary peritonitis