Actively 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
Led by Fondazione IRCCS Policlinico San Matteo di Pavia · Updated on 2025-04-09
62
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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) in two stage procedures (control group) or ELC + Spyglass cholangiography (study group). The follow-up will be performed after 30 days and 6 months from intervention with an outpatient medical examination
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a diagnosis of Acute Calculous Cholecystitis (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 older than 18 years
- Onset of symptoms 7 days or less before Emergency Department 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.
You will not qualify if you...
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients diagnosed with concomitant cholangitis or pancreatitis
- Acute cholecystitis not related to a gallstone cause
- Onset of symptoms more than 7 days before Emergency Department admission
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach, or duodenum
- Biliary peritonitis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
L
Luca Ansaloni, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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