Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorOulu University Hospital

About this trial

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 criteria

Qualifiers

Age 75 years or older.

Radiologically confirmed acute cholecystitis.

Elevated inflammatory parameters.

Able to provide written informed consent.

Disqualifiers

Age under 75 years.

Considered unfit for surgery.

ASA physical status classification below III.

Unwillingness to participate in follow-up assessments.

Trial design

Treatments tested in this trial

  • LCC
  • EUS-GBD

Treatment groups

116 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oulu University Hospital

Lead sponsor

University of Eastern Finland

Collaborator

Kuopio University Hospital

Collaborator

North Karelia Central Hospital

Collaborator