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
NCT ID: NCT06918626
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2024-02-18
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients who receive ELC + Spyglass cholangiography
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.
Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Luca Ansaloni
MD
Locations
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Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INACCESSIBLE
Identifier Type: -
Identifier Source: org_study_id
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