Acute Calculous Cholecystitiis (ACC)
Conditions
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
Interventions
PROCEDUREELC + 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.
PROCEDUREERCP + 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.
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Total readmission rate within 6 months | 6 Months after procedure |
| Readmission rate within 6 months due to Gallstones Relates Events (GRE) | 6 Months after procedure |
| 30-day postoperative complication rate according to Clavien Dindo | Day 30 |
| 30-day postoperative biliary complication rate | Day 30 |
| 30-day postoperative mortality rate | Day 30 |
| Total length of stay (T-LOS) | immediately after the procedures |
| Failure rate of performing the procedure | Day 0 |
| Operative times | Day 0 |
| Conversion to open surgery rate | Day 0 |
| Need of ERCP after in LC + Spyglass cholangiography group | immediately after the procedures, Day 30, 6 months |
| Postoperative length of stay (PO-LOS) | immediately after the procedures |
| Intraoperative complication rate | Day 0 |
Countries
Italy
Contacts
Primary ContactLuca Ansaloni, MD
Outcome results
None listed