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

Fondazione IRCCS Policlinico San Matteo di Pavia62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Acute Calculous Cholecystitiis (ACC)

Interventions

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 proceduresPROCEDURE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Timing of ELC after diagnosis of ACC

The rate of patients who perform ELC within 72 hours after ACC diagnosis.

Time frame: At the end of the procedures.

Secondary Outcomes

30-day postoperative complication rate according to Clavien Dindo

Time frame: Day 30

30-day postoperative biliary complication rate

Time frame: Day 30

30-day postoperative mortality rate

Time frame: Day 30

Intraoperative complication rate

Time frame: Day 0

Failure rate of performing the procedure

Time frame: Day 0

Operative times

Time frame: Day 0

Conversion to open surgery rate

Time frame: Day 0

Need of ERCP after in LC + Spyglass cholangiography group

Time frame: immediately after the procedures, Day 30, 6 months

Postoperative length of stay (PO-LOS)

Time frame: immediately after the procedures

Total length of stay (T-LOS)

Time frame: immediately after the procedures

Total readmission rate within 6 months

Time frame: 6 Months after procedure

Readmission rate within 6 months due to Gallstones Relates Events (GRE)

Time frame: 6 Months after procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts