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Compares treatment options for High-risk Patients With Acute Calculous Cholecystitis (ACC)
Official title Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
ClinicalTrials.gov ID: NCT06918652
What this study is testing
- What it's testing
- Randomized controlled trial on high-risk patients with ACC. Consecutive patients with a diagnosis of ACC, if they meet the inclusion and exclusion criteria, will be randomized to receive Laparoscopic cholecystectomy (LC) or transmural ultrasound-guided gallbladder drainage (TUGD) with lumen-apposing self-expandable metal stents (LAMSs) within 10 days from onset of symptoms.
- 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
- be ≥ 18 years old
- have a POSSUM PS ≥ 25
- 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 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
- be ≥ 18 years old
- have a POSSUM PS ≥ 25
- onset of symptoms \<= 7 days before Emergency Department (ED) admission
- provide signed and dated informed consent form
- willing to comply with all study procedures and be available for the duration of the study
- have an Israelian Score (IS) (Table 3) for the risk of main bile duct stones \<2 or an IS =2 and an EUS or a MRCP negative for main bile duct stones
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients diagnosed with concomitant 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
- Previous drainage of the gallbladder
- 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.