RecruitingNot Applicable

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

Italy62 participantsStarted 2024-02-18

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Timing of ELC after diagnosis of ACC

Timeframe: At the end of the procedures.

Trial details

NCT IDNCT06918626

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-30

Contact for this trial

Luca Ansaloni, MD

+39 0382 50 2530 l.ansaloni@smatteo.pv.it