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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 75
Healthy Volunteers: f
View:

• Age 75 years or older.

• Radiologically confirmed acute cholecystitis.

• Elevated inflammatory parameters.

• Able to provide written informed consent.

• Able to complete follow-up questionnaires.

Locations
Other Locations
Finland
Oulu University Hospital
RECRUITING
Oulu
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2036-02-27
Participants
Target number of participants: 116
Treatments
Active_comparator: LCC
Laparoscopic cholecystectomy
Experimental: EUS-GBD
Endoscopic ultrasonography-guided gallbladder drainage
Sponsors
Collaborators: University of Eastern Finland, North Karelia Central Hospital, Kuopio University Hospital
Leads: Oulu University Hospital

This content was sourced from clinicaltrials.gov

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