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

NARecruitingINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

February 18, 2024

Primary Completion Date

May 30, 2025

Study Completion Date

November 30, 2025

Conditions
Acute Calculous Cholecystitiis (ACC)
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (1)

27100

RECRUITING

Fondazione IRCCS Policlinico San Matteo, Pavia

All Listed Sponsors
lead

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER