RecruitingNot ApplicableNCT07678541

Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD

Recurrence of Acute Cholecystitis After EUS-Guided Gallbladder Drainage Versus Cholecystectomy in Elderly Patients: A Multicenter Randomized Controlled Trial

Sponsor

Oulu University Hospital

Enrollment

116 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Cholecystitis

Summary

Acute cholecystitis is common in elderly patients and becomes more frequent with increasing age. Standard treatment is laparoscopic cholecystectomy (LCC), but operative treatment may be associated with increased risk in older patients with substantial comorbidity or reduced tolerance of general anesthesia. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is a minimally invasive internal drainage procedure performed through the stomach or duodenum using endoscopic ultrasound guidance and a lumen-apposing metal stent. This approach may provide an alternative to operative treatment in selected elderly patients. The CHOICE study (CHolecystitis Outcomes in the Investigation of Cholecystectomy versus EUS-GBD) is a multicenter randomized controlled trial comparing EUS-GBD with LCC in patients aged 75 years or older with acute cholecystitis. Participants are randomly assigned to undergo either laparoscopic removal of the gallbladder or endoscopic ultrasound-guided internal gallbladder drainage. The objective of the study is to determine whether EUS-GBD provides clinically acceptable outcomes compared with standard operative treatment in this patient population. Participants are followed using medical record review and scheduled follow-up contacts.

Eligibility

Min Age: 75 Years

Inclusion Criteria5

Age 75 years or older.
Radiologically confirmed acute cholecystitis.
Elevated inflammatory parameters.
Able to provide written informed consent.
Able to complete follow-up questionnaires.

Exclusion Criteria6

Age under 75 years.
Considered unfit for surgery.
ASA physical status classification below III.
Unwillingness to participate in follow-up assessments.
Lack of written informed consent.
Clinical Frailty Scale score of 8 or higher.

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Interventions

PROCEDURELCC

Laparoscopic cholecystectomy for acute cholecystitis is performed according to each participating hospital's standard operative practice. Briefly, a four-port laparoscopic technique is used. The gallbladder is retracted at the fundus, and the cystic duct and cystic artery are dissected as separate structures. The posterior aspect of the gallbladder is dissected from the liver bed to achieve the critical view of safety. After this has been confirmed, the cystic duct and cystic artery are clipped and divided. The gallbladder is then separated from the liver bed, and the specimen is extracted through one of the port incisions.

PROCEDUREEUS-GBD

EUS-GBD is performed under propofol sedation without airway protection. After sedation, the echoendoscope is advanced through the esophagus into the stomach and duodenum. The gallbladder is identified by ultrasonography, and the optimal site for LAMS placement is determined. The preferred approach is transduodenal access with cholecystoduodenostomy. If safe cystotome puncture cannot be achieved through this route, a transgastric approach with cholecystogastrostomy is used. The operator selects the appropriate LAMS according to the clinical situation, with a 15-mm LAMS used as the standard choice in most cases.