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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: High-risk Patients With Acute Calculous Cholecystitis (ACC)

Treatments: Procedure: Transmural ultrasound-guided gallbladder drainage; Procedure: Laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06918652

SETIMIHRACC

Details and patient eligibility

About

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. Blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. Bile samples will be taken during the procedure for microbiological exam and culture. Blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure.

The follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Transmural ultrasound-guided gallbladder drainage

Experimental group

Description:

Patients randomized to TUGD arm will receive endoscopic transmural ultrasound-guided gallbladder drainage with lumen-apposing self-expandable metal stents (LAMSs)

Treatment:

Procedure: Transmural ultrasound-guided gallbladder drainage

Laparoscopic cholecystectomy

Active Comparator group

Description:

Patients randomized to control arm (LC) will receive laparoscopic cholecystectomy.

Treatment:

Procedure: Laparoscopic cholecystectomy