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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
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.
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.
Oulu University Hospital
Oulu, Oulu, Finland
RECRUITINGRecurrence rate of cholecystitis within 24 months
Proportion of participants with recurrent acute cholecystitis within 24 months after the index intervention. Recurrent cholecystitis is defined as a new episode of clinically suspected acute cholecystitis supported by radiological findings and elevated inflammatory parameters.
Time frame: From the index intervention to 24 months after the index intervention
Length of index hospital stay
Duration of the index hospital stay, measured in days from hospital admission for acute cholecystitis to discharge from the index hospitalization.
Time frame: From hospital admission for acute cholecystitis to discharge from the index hospitalization, assessed up to 90 days
Duration of antibiotic treatment
Total duration of antibiotic treatment for the index episode of acute cholecystitis, measured in days.
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
Total duration of intensive care unit stay after the index intervention, measured in days.
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
Proportion of participants with complications after the index intervention, classified according to the Clavien-Dindo classification.
Time frame: From the index intervention to 90 days after the index intervention
Organ-specific postoperative complications
Proportion of participants with organ-specific postoperative complications after the index intervention.
Time frame: From the index intervention to 90 days after the index intervention
Procedure-specific complications
Proportion of participants with any complication specifically related to the allocated intervention, including complications related to laparoscopic cholecystectomy in the surgical group and complications related to endoscopic ultrasound-guided gallbladder drainage in the EUS-GBD group.
Time frame: From the index intervention to 90 days after the index intervention
Ninety-day mortality
Proportion of participants who die from any cause within 90 days after the index intervention.
Time frame: From the index intervention to 90 days after the index intervention
Long-term mortality
Proportion of participants who die from any cause during long-term follow-up.
Time frame: From the index intervention to 10 years after the index intervention
Long-term recurrence of cholecystitis after 24 months
Proportion of participants with recurrent acute cholecystitis occurring after the first 24 months of follow-up and during long-term follow-up after the index intervention.
Time frame: From 24 months after the index intervention to 10 years after the index intervention
Direct hospital costs
Direct hospital costs related to treatment of acute cholecystitis and subsequent related hospital care, measured in euros.
Time frame: From hospital admission for acute cholecystitis to 24 months after the index intervention
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