Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
Recruiting
N/A
Interventional Study
High-risk Patients With Acute Calculous Cholecystitis (ACC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 80 (estimated)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Other
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About This Trial
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 …
Trial Locations
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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 proced…
Contacts