Comparing surgical and endoscopic treatments for high-risk acute gallbladder inflammation
Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
This study is testing whether surgery or a less invasive procedure works better for high-risk patients with severe gallbladder inflammation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06918652 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with conditions such as pregnancy, pancreatitis, or altered gastrointestinal anatomy may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pavia, Pavia
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.