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Clinical Trials in Italy / NCT06918626
Recruiting Not applicable

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

NCT06918626 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Not applicable
Started
2024-02-18
Last updated
2025-04-09

Condition(s) studied

Acute Calculous Cholecystitiis (ACC)

Investigational drug(s) / intervention(s)

ELC + Spyglass cholangiographyERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

ELC + Spyglass cholangiography: Study group (Spyglass Discover). Patients will undergo ELC surgery as soon as the ACC diagnosis has been confirmed. During surgery, intra-operative cholangiograpy (IOC) will be performed in order to exclude the presence of CBDS and in case of confirmation or still suspicion of CBDS, the exploration of the common bile duct and its eventual clearance via Spyglass Discover is carried out during ELC.

ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures: Control group (ELC sequential treatment after possible clearance of CBDS via ERCP). Following the diagnosis of ACC, patients with CBDS high/intermediate risk are introduced either directly, in case of high risk, or after performing second-level diagnostics (MNR cholangiography or endoscopic ultrasound), in the case of intermediate risk, to the ERCP with the aim of eliminating CBDS preoperatively and then the ELC will be performed.

Study 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, 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Timing of ELC after diagnosis of ACC — At the end of the procedures.
    The rate of patients who perform ELC within 72 hours after ACC diagnosis.

Trial sites (1)

FacilityCityRegionStatus
Fondazione IRCCS Policlinico San Matteo Pavia Pavia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06918626 on ClinicalTrials.gov ↗ ← All trials in Italy