Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD

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.

Conditions

• Acute Cholecystitis

Interventions

PROCEDURE

LCC

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.

PROCEDURE

EUS-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.

Sponsors & Collaborators

• University of Eastern Finland

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• North Karelia Central Hospital

  collaborator OTHER

• Oulu University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-02-28

Completion

2036-02-27

Countries

• Finland

Study Locations