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Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis

Study acronym: SETIMIHRACC
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 9, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06918652
Lead Sponsor Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions
(from sponsor)		 High-risk Patients With Acute Calculous Cholecystitis (ACC)
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov