Comparing two methods for treating acute gallbladder inflammation with potential bile duct stones
Official title: 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
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06918626 · Data updated 2026-11-12
This study tests two different ways to treat acute gallbladder inflammation in patients who might have bile duct stones to see which method works better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | February 18, 2024 |
| Main results expected | May 30, 2025 |
| Study ends | November 30, 2025 |
| Registry record updated | April 9, 2025 |
| Trial ID | NCT06918626 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults over 18 with a diagnosis of ACC and an Israelian Score of 2 or 3, who have experienced symptoms for 7 days or less.
✕Probably not a fit
Patients with conditions such as pregnancy, cholangitis, pancreatitis, or those with altered gastrointestinal anatomy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates two treatment strategies for patients with Acute Calculous Cholecystitis (ACC) who are at intermediate to high risk for common bile duct stones. Participants will be randomly assigned to either a control group receiving ERCP followed by Early Laparoscopic Cholecystectomy (ELC) in two stages, or a study group receiving ELC combined with Spyglass cholangiography. The study aims to determine the effectiveness of these approaches in managing the condition and preventing complications. Follow-up assessments will occur at 30 days and 6 months post-intervention.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and reduced complications for patients with acute gallbladder inflammation and bile duct stones.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with bile duct stones.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Luca Ansaloni, MD
- Email: l.ansaloni@smatteo.pv.it
- Phone: +39 0382 50 2530
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.