Clinical trial NCT06918626: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Calculous Cholecystitiis (ACC)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria: 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 outcomes:
measure: Timing of ELC after diagnosis of ACC
timeFrame: At the end of the procedures.
Secondary outcomes:
measure: 30-day postoperative complication rate according to Clavien Dindo
timeFrame: Day 30
measure: 30-day postoperative biliary complication rate
timeFrame: Day 30
measure: 30-day postoperative mortality rate
timeFrame: Day 30
measure: Intraoperative complication rate
timeFrame: Day 0
measure: Failure rate of performing the procedure
timeFrame: Day 0
measure: Operative times
timeFrame: Day 0
measure: Conversion to open surgery rate
timeFrame: Day 0
measure: Need of ERCP after in LC + Spyglass cholangiography group
timeFrame: immediately after the procedures, Day 30, 6 months
measure: Postoperative length of stay (PO-LOS)
timeFrame: immediately after the procedures
measure: Total length of stay (T-LOS)
timeFrame: immediately after the procedures
measure: Total readmission rate within 6 months
timeFrame: 6 Months after procedure
measure: Readmission rate within 6 months due to Gallstones Relates Events (GRE)
timeFrame: 6 Months after procedure
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
Study officials:
References: