Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatment options for patients who are at high risk for complications from a serious condition called acute calculous cholecystitis (ACC), which is inflammation of the gallbladder due to gallstones. Participants will be randomly assigned to receive either laparoscopic cholecystectomy (a minimally invasive surgery to remove the gallbladder) or a less invasive procedure called transmural ultrasound-guided gallbladder drainage, which uses special tools to drain the gallbladder without surgery. The goal is to find out which approach is more effective for these high-risk patients.

To be eligible for the trial, participants must be at least 18 years old and have a diagnosis of ACC that meets specific medical guidelines. They should have experienced symptoms for no more than a week before coming to the emergency room and must be willing to follow the study procedures and attend follow-up appointments. During the trial, participants will undergo some tests, including blood samples and cultures, to monitor their health before and after the procedure. After the treatment, they will have check-ups at 30 days and again at 6 months to see how they are doing. This study is currently recruiting participants, and all genders are welcome to join.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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