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 (INACCESSIBLE)

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 Overview

• Status: Recruiting
• Conditions: Acute Calculous Cholecystitiis (ACC)
• Intervention / Treatment: Procedure: ELC + Spyglass cholangiography; Procedure: ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luca Ansaloni, MD; Phone Number: +39 0382 50 2530; Email: l.ansaloni@smatteo.pv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • Fondazione IRCCS Policlinico San Matteo
    • Contact: Luca Ansaloni, MD; Phone Number: +390382502530; Email: l.ansaloni@smatteo.pv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who receive ELC + Spyglass cholangiography	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.
Active Comparator: Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Calculi; Cholecystitis; Acalculous Cholecystitis
• Other Study ID Numbers: INACCESSIBLE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No