Comparing surgical and endoscopic treatments for high-risk acute gallbladder inflammation
Official title: Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06918652 · Data updated 2026-11-12
This study is testing whether surgery or a less invasive procedure works better for high-risk patients with severe gallbladder inflammation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | October 20, 2023 |
| Main results expected | December 2025 |
| Study ends | December 2025 |
| Registry record updated | April 9, 2025 |
| Trial ID | NCT06918652 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosis of acute calculous cholecystitis and a specific risk profile as defined by the study criteria.
✕Probably not a fit
Patients with conditions such as pregnancy, pancreatitis, or 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 investigates the effectiveness of laparoscopic cholecystectomy versus transmural ultrasound-guided gallbladder drainage in high-risk patients diagnosed with acute calculous cholecystitis. Eligible participants will be randomly assigned to one of the two treatment groups within 10 days of symptom onset. The study will involve blood cultures and bile sample collection to assess microbiological outcomes, with follow-up evaluations scheduled at 30 days and 6 months post-intervention. The aim is to determine which treatment approach offers better outcomes for patients with this condition.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment for high-risk patients with acute calculous cholecystitis, potentially improving patient outcomes.
How similar studies have gone: While there have been studies on treatments for acute cholecystitis, this specific comparison of surgical versus endoscopic approaches in high-risk patients is relatively novel.
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 * be ≥ 18 years old * have a POSSUM PS ≥ 25 * onset of symptoms \<= 7 days before Emergency Department (ED) admission * provide signed and dated informed consent form * willing to comply with all study procedures and be available for the duration of the study * have an Israelian Score (IS) (Table 3) for the risk of main bile duct stones \<2 or an IS =2 and an EUS or a MRCP negative for main bile duct stones Exclusion Criteria: * Pregnancy * Patients unwilling to undergo follow-up assessments * Patients diagnosed with concomitant 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 * Previous drainage of the gallbladder * Biliary peritonitis
Where it's running
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SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy Recruiting
Study contacts
- Principal investigator: Luca Ansaloni, MD — Fondazione IRCCS Policlinico San Matteo di Pavia
- Study coordinator: Luca Ansaloni, MD
- Email: l.andaloni@smatteo.pv.it
- Phone: +390382502530
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.