Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD

The CHOICE trial is an investigator-initiated, multicenter, randomized controlled trial conducted in Finnish hospitals. The trial compares endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with laparoscopic cholecystectomy (LCC) in elderly patients with acute cholecystitis.

LCC is the standard operative treatment for acute cholecystitis. In elderly patients, clinical decision-making may be affected by comorbidity, frailty, reduced physiological reserve, and limited tolerance of general anesthesia. EUS-GBD is an internal drainage procedure performed under endoscopic ultrasound guidance using a lumen-apposing metal stent. The procedure is intended to achieve gallbladder drainage without surgical removal of the gallbladder.

After enrolment, participants are randomized in a 1:1 ratio to either LCC or EUS-GBD using centralized computer-generated allocation through REDCap. Both treatment groups receive standard antimicrobial treatment according to local clinical practice.

LCC is performed according to the standard operative practice of each participating hospital using a laparoscopic approach. EUS-GBD is performed under propofol sedation with endoscopic ultrasound guidance. The preferred access route is transduodenal, with transgastric access used when required by anatomical or technical factors. A lumen-apposing metal stent is placed to create internal drainage between the gallbladder and the gastrointestinal tract.

In the EUS-GBD group, stent management is planned according to the study protocol and clinical circumstances. In general, the lumen-apposing metal stent may be replaced with a plastic pigtail stent after maturation of the fistulous tract. In patients with limited life expectancy or other clinical considerations, the lumen-apposing metal stent may be left in place at the discretion of the treating physician.

Study data are collected prospectively using electronic case report forms in a secure REDCap database. Data collection includes baseline clinical characteristics, procedural details, treatment delivery, subsequent interventions, and follow-up information obtained from medical records and scheduled follow-up contacts. Participants are identified in the study database by study ID, and personal identifiers are not used in the analysis dataset.

The primary analysis follows the intention-to-treat principle. Additional analyses may be performed to account for cases in which allocated treatment is not delivered as planned or in which treatment is changed after randomization. The trial includes planned safety monitoring according to predefined criteria.

The purpose of the trial is to generate prospective comparative evidence on whether EUS-GBD can be incorporated into the treatment pathway of elderly patients with acute cholecystitis as a less invasive alternative to laparoscopic cholecystectomy in routine hospital practice.

• Duration of antibiotic treatment [Time frame: From hospital admission for acute cholecystitis to completion of antibiotic treatment for the index episode, assessed up to 90 days]
• Length of intensive care unit stay [Time frame: From the index intervention to hospital discharge from the index hospitalization, assessed up to 90 days]
• Post-interventional complications according to the Clavien-Dindo classification [Time frame: From the index intervention to 90 days after the index intervention]
• Organ-specific postoperative complications [Time frame: From the index intervention to 90 days after the index intervention]
• Procedure-specific complications [Time frame: From the index intervention to 90 days after the index intervention]
• Ninety-day mortality [Time frame: From the index intervention to 90 days after the index intervention]
• Long-term mortality [Time frame: From the index intervention to 10 years after the index intervention]
• Long-term recurrence of cholecystitis after 24 months [Time frame: From 24 months after the index intervention to 10 years after the index intervention]
• Direct hospital costs [Time frame: From hospital admission for acute cholecystitis to 24 months after the index intervention]