Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD
ConditionAcute Cholecystitis
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
LCC
Procedure/SurgeryLaparoscopic 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
Procedure/SurgeryEUS-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.
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: LCCActive comparator 1 intervention
Group B: EUS-GBDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the index intervention to 24 months after the index intervention2
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 daysSecondary outcomes
1
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 days2
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 days3
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 intervention4
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 interventionSponsors and contacts
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Oulu University Hospital
Lead sponsor
University of Eastern Finland
Collaborator
Kuopio University Hospital
Collaborator
North Karelia Central Hospital
Collaborator
Source ClinicalTrials.gov