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 now · Not applicable
Conditions studied: Acute Calculous Cholecystitiis (ACC)
In brief
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
Key facts
- Study ID
- NCT06918626
- Run by
- Fondazione IRCCS Policlinico San Matteo di Pavia
- People needed
- 62
- Starts
- 2024-02-18
- Expected to finish
- 2025-11-30
- Last updated by the study team
- 2025-04-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Fondazione IRCCS Policlinico San Matteo — Pavia, Pavia, Italy (enrolling)
Full record on ClinicalTrials.gov
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