Status:
RECRUITING
Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
High-risk Patients With Acute Calculous Cholecystitis (ACC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06918652
Start Date
October 20 2023
End Date
December 1 2025
Last Update
April 9 2025
Active Locations (1)
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1
SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy, 27100