NCT06918652 Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
| NCT ID | NCT06918652 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia |
| Condition | High-risk Patients With Acute Calculous Cholecystitis (ACC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-10-20 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Randomized controlled trial on high-risk patients with ACC. Consecutive patients with a diagnosis of ACC, if they meet the inclusion and exclusion criteria, will be randomized to receive Laparoscopic cholecystectomy (LC) or transmural ultrasound-guided gallbladder drainage (TUGD) with lumen-apposing self-expandable metal stents (LAMSs) within 10 days from onset of symptoms. Blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. Bile samples will be taken during the procedure for microbiological exam and culture. Blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. The follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.
Eligibility 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
Contact & Investigator
Luca Ansaloni, MD
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Policlinico San Matteo di Pavia
Frequently Asked Questions
Who can join the NCT06918652 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying High-risk Patients With Acute Calculous Cholecystitis (ACC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06918652 currently recruiting?
Yes, NCT06918652 is actively recruiting participants. Contact the research team at l.andaloni@smatteo.pv.it for enrollment information.
Where is the NCT06918652 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06918652 clinical trial?
NCT06918652 is sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. The principal investigator is Luca Ansaloni, MD at Fondazione IRCCS Policlinico San Matteo di Pavia. The trial plans to enroll 80 participants.