Acute Calculous Cholecystitiis (ACC)INACCESSIBLENCT06918626
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
A study testing ELC + Spyglass cholangiography and ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures in people with Acute Calculous Cholecystitiis (ACC), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Calculous Cholecystitiis (ACC)
- What is being tested?
- ELC + Spyglass cholangiography and ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 18 Feb 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
Luca Ansaloni, MD, +390382502530, l.ansaloni@smatteo.pv.it
About this study
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
- Conditions
- Acute Calculous Cholecystitiis (ACC)
- Being tested
- ELC + Spyglass cholangiography, ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELC + Spyglass cholangiographyProcedure or surgery
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.
ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage proceduresProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive ELC + Spyglass cholangiography | Experimental | Not described Receives: Procedure: ELC + Spyglass cholangiography |
| Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures | Active comparator | Not described Receives: Procedure: ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of ELC after diagnosis of ACC
The rate of patients who perform ELC within 72 hours after ACC diagnosis.
Measured: At the end of the procedures.
Secondary outcomes (12)
30-day postoperative complication rate according to Clavien Dindo
Measured: Day 30
30-day postoperative biliary complication rate
Measured: Day 30
30-day postoperative mortality rate
Measured: Day 30
Intraoperative complication rate
Measured: Day 0
Failure rate of performing the procedure
Measured: Day 0
Operative times
Measured: Day 0
Conversion to open surgery rate
Measured: Day 0
Need of ERCP after in LC + Spyglass cholangiography group
Measured: immediately after the procedures, Day 30, 6 months
Postoperative length of stay (PO-LOS)
Measured: immediately after the procedures
Total length of stay (T-LOS)
Measured: immediately after the procedures
Total readmission rate within 6 months
Measured: 6 Months after procedure
Readmission rate within 6 months due to Gallstones Relates Events (GRE)
Measured: 6 Months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start18 Feb 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Calculous Cholecystitiis (ACC)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ansaloni, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918626
- Sponsor's protocol ID
- INACCESSIBLE
- Acronym
- INACCESSIBLE
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06918626
- Acronym / sponsor ID
- INACCESSIBLE / INACCESSIBLE
- Conditions
- Acute Calculous Cholecystitiis (ACC)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who receive ELC + Spyglass cholangiography | Experimental | Procedure: ELC + Spyglass cholangiography |
| Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures | Active comparator | Procedure: ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELC + Spyglass cholangiographyStudy 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. | Procedure or surgery | Patients who receive ELC + Spyglass cholangiography |
| ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage proceduresControl 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. | Procedure or surgery | Patients who receive ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures |
Primary outcome
Timing of ELC after diagnosis of ACC
Time frame: At the end of the procedures.
The rate of patients who perform ELC within 72 hours after ACC diagnosis.
12 secondary outcomes
30-day postoperative complication rate according to Clavien Dindo
Time frame: Day 30
30-day postoperative biliary complication rate
Time frame: Day 30
30-day postoperative mortality rate
Time frame: Day 30
Intraoperative complication rate
Time frame: Day 0
Failure rate of performing the procedure
Time frame: Day 0
Operative times
Time frame: Day 0
Conversion to open surgery rate
Time frame: Day 0
Need of ERCP after in LC + Spyglass cholangiography group
Time frame: immediately after the procedures, Day 30, 6 months
Postoperative length of stay (PO-LOS)
Time frame: immediately after the procedures
Total length of stay (T-LOS)
Time frame: immediately after the procedures
Total readmission rate within 6 months
Time frame: 6 Months after procedure
Readmission rate within 6 months due to Gallstones Relates Events (GRE)
Time frame: 6 Months after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELC + Spyglass cholangiography and ERCP + Early Laparoscopic cholecystectomy (ELC) in two stage procedures in people with Acute Calculous Cholecystitiis (ACC), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Ansaloni, MD (+39 0382 50 2530, l.ansaloni@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of ELC after diagnosis of ACC (time frame: At the end of the procedures.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.