Status:
RECRUITING
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
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Acute Calculous Cholecystitiis (ACC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, accor...
Eligibility Criteria
Inclusion
- 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 consent form
- be willing to comply with all study procedures and be available for the duration of the study.
Exclusion
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients diagnosed with concomitant cholangitis or 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
- Biliary peritonitis
Key Trial Info
Start Date :
February 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06918626
Start Date
February 18 2024
End Date
November 30 2025
Last Update
April 9 2025
Active Locations (1)
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1
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100