INtraoperative Approach With Eventual Clearance of Common bilE Duct by SpyGlass Discover vs Sequential Strategy in Patients With Acute Calculus Cholecystitis and Intermediate/High Risk of Common BiLE Duct Stone
Recruiting
N/A
Interventional Study
Acute Calculous Cholecystitiis (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
- 62 (estimated)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Other
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About This Trial
INACCESSIBLE trial is a randomized controlled study that compares two different strategies for the treatment of Acute Calculous Cholecystitiis (ACC) patients with high/intermediate risk of CBDS, according to the score by Khoury T (named Israelian Score, IS). If a patient meets the inclusion and exclusion criteria, (s)he will be randomized to receive ERCP + Early Laparoscopic cholecystectomy (ELC) …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
* have an Israelian Score (IS) for the risk of main bile duct stones of 2 or 3
* be \>18 years old
* onset of symptoms ≤7 days before Emergency Department (ED) admission
* provide signed and dated informed co…
Contacts