Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD

NCT07678541 | Recruiting DMC

• 2 other identifiers: 29/2025EETTMK: 29/2025
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

EUS-GBD; LCC; Acute Cholecystitis

Outcome Measures

Primary Outcomes (2)

• Recurrence 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.

  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.

  From hospital admission for acute cholecystitis to discharge from the index hospitalization, assessed up to 90 days

Secondary Outcomes (9)

• Duration of antibiotic treatment

  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

  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

  From the index intervention to 90 days after the index intervention

• Organ-specific postoperative complications

  From the index intervention to 90 days after the index intervention

• Procedure-specific complications

  From the index intervention to 90 days after the index intervention

Study Arms (2)

LCC

ACTIVE COMPARATOR

Laparoscopic cholecystectomy

Procedure: LCC

EUS-GBD

EXPERIMENTAL

Endoscopic ultrasonography-guided gallbladder drainage

Procedure: EUS-GBD

Interventions

LCC PROCEDURE

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.

LCC

EUS-GBD PROCEDURE

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.

EUS-GBD

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 75 years or older.
• Radiologically confirmed acute cholecystitis.
• Elevated inflammatory parameters.
• Able to provide written informed consent.
• Able to complete follow-up questionnaires.

You may not qualify if:

• Age under 75 years.
• Considered unfit for surgery.
• ASA physical status classification below III.
• Unwillingness to participate in follow-up assessments.
• Lack of written informed consent.
• Clinical Frailty Scale score of 8 or higher.

Sponsors & Collaborators

• Oulu University Hospital: lead
• University of Eastern Finland: collaborator
• Kuopio University Hospital: collaborator
• North Karelia Central Hospital: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, Oulu, 90220, Finland

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: July 1, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 27, 2036
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)