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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who receive ELC + Spyglass cholangiography | Experimental |
| |
| Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELC + Spyglass cholangiography | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of ELC after diagnosis of ACC | The rate of patients who perform ELC within 72 hours after ACC diagnosis. | At the end of the procedures. |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day postoperative complication rate according to Clavien Dindo | Day 30 | |
| 30-day postoperative biliary complication rate | Day 30 | |
| 30-day postoperative mortality rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Ansaloni, MD | Contact | +39 0382 50 2530 | l.ansaloni@smatteo.pv.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Pavia | 27100 | Italy |
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| ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures | Procedure | 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. |
|
| Day 30 |
| Intraoperative complication rate | Day 0 |
| 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 |
| Total length of stay (T-LOS) | immediately after the procedures |
| 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 |
| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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