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 (INACCESSIBLE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Acute Calculous Cholecystitiis (ACC)

Treatments: Procedure: ELC + Spyglass cholangiography; Procedure: ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

Study type: Interventional

Funder types: Other

Identifiers

NCT06918626

INACCESSIBLE

Details and patient eligibility

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

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 consent form
• be willing to comply with all study procedures and be available for the duration of the study.

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Patients who receive ELC + Spyglass cholangiography

Experimental group

Treatment:

Procedure: ELC + Spyglass cholangiography

Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

Active Comparator group

Treatment:

Procedure: ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures