ClinicalTrials.gg
Sign In
RecruitingNCT06918626INACCESSIBLEUpdated Apr 9, 2025

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

An interventional study of ELC + Spyglass cholangiography and ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures in Acute Calculous Cholecystitiis (ACC), sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 1 month after the study started (first participant enrolled Feb 2024, registered Mar 2025).
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Acute Calculous Cholecystitiis (ACC)
03

In context

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 257 studies on the registry; 114 are open to participants now.

Browse Fondazione IRCCS Policlinico San Matteo di Pavia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Patients who receive ELC + Spyglass cholangiography

    Procedure: ELC + Spyglass cholangiography

  • Active comparator
    Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

    Procedure: ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures

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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 30-day postoperative complication rate according to Clavien Dindo

    Time frame: Day 30

  2. 30-day postoperative biliary complication rate

    Time frame: Day 30

  3. 30-day postoperative mortality rate

    Time frame: Day 30

  4. Intraoperative complication rate

    Time frame: Day 0

  5. Failure rate of performing the procedure

    Time frame: Day 0

  6. Operative times

    Time frame: Day 0

  7. Conversion to open surgery rate

    Time frame: Day 0

  8. Need of ERCP after in LC + Spyglass cholangiography group

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

  9. Postoperative length of stay (PO-LOS)

    Time frame: immediately after the procedures

  10. Total length of stay (T-LOS)

    Time frame: immediately after the procedures

  11. Total readmission rate within 6 months

    Time frame: 6 Months after procedure

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

    Time frame: 6 Months after procedure

07

Study locations

1 of 1 sites recruiting
  • Fondazione IRCCS Policlinico San Matteo
    Pavia, Pavia 27100, Italy
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2024 (actual). Primary completion is estimated for May 2025, 15 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2025
First posted
Apr 9, 2025
StartActual
Feb 18, 2024
Primary completionEst.
May 30, 2025
CompletionEst.
Nov 30, 2025
Last update
Apr 9, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06918626
Lead sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible party
Luca Ansaloni (MD, Fondazione IRCCS Policlinico San Matteo di Pavia) — Principal investigator
First posted
Apr 9, 2025
Start date
Feb 18, 2024
Primary completion
May 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Apr 9, 2025

Study contacts

Luca Ansaloni, MD
Contact
l.ansaloni@smatteo.pv.it
+39 0382 50 2530

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia →

Start the discussion