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Compares treatment options for Acute Calculous Cholecystitiis (ACC)
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
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Pavia, Pavia, Italy
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pavia, Pavia, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.