Acute CholecystitisCHOICENCT07678541
Cholecystitis Outcomes in the Investigation of Cholecystectomy Versus EUS-GBD
A study testing LCC and EUS-GBD in people with Acute Cholecystitis, run by Oulu University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- LCC and EUS-GBD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2026to 27 Feb 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 75 years or older.
- Radiologically confirmed acute cholecystitis.
- Elevated inflammatory parameters.
- Able to provide written informed consent.
- Able to complete follow-up questionnaires.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Oulu University Hospital
Oulu, Oulu, 90220
Heikki Huhta, Ph.D, +368414324589, heikki.huhta@oulu.fi
Heikki Huhta, Ph.D
About this study
Official title: Recurrence of Acute Cholecystitis After EUS-Guided Gallbladder Drainage Versus Cholecystectomy in Elderly Patients: A Multicenter Randomized Controlled 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Acute Cholecystitis
- Being tested
- LCC, EUS-GBD
- Keywords
- EUS-GBD, LCC, Acute Cholecystitis
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCCProcedure or surgery
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-GBDProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| LCC | Active comparator | Laparoscopic cholecystectomy Receives: Procedure: LCC |
| EUS-GBD | Experimental | Endoscopic ultrasonography-guided gallbladder drainage Receives: Procedure: EUS-GBD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From hospital admission for acute cholecystitis to discharge from the index hospitalization, assessed up to 90 days
Secondary outcomes (9)
Duration of antibiotic treatment
Total duration of antibiotic treatment for the index episode of acute cholecystitis, measured in days.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From hospital admission for acute cholecystitis to 24 months after the index intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Feb 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion27 Feb 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute CholecystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, Kuopio University Hospital, North Karelia Central Hospital
- Responsible party
- Principal investigator, Heikki Huhta, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678541
- Sponsor's protocol ID
- 29/2025
- Other IDs
- EETTMK: 29/2025
- Acronym
- CHOICE
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrence of Acute Cholecystitis After EUS-Guided Gallbladder Drainage Versus Cholecystectomy in Elderly Patients: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07678541
- Acronym / sponsor ID
- CHOICE / 29/2025
- Conditions
- Acute Cholecystitis
- Keywords
- EUS-GBD, LCC, Acute Cholecystitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland, Kuopio University Hospital, North Karelia Central Hospital
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 27 Feb 2036 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCC | Active comparator | Procedure: LCCLaparoscopic cholecystectomy |
| EUS-GBD | Experimental | Procedure: EUS-GBDEndoscopic ultrasonography-guided gallbladder drainage |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 75 years or older.
- Radiologically confirmed acute cholecystitis.
- Elevated inflammatory parameters.
- Able to provide written informed consent.
- Able to complete follow-up questionnaires.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LCCLaparoscopic 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 or surgery | LCC |
| EUS-GBDEUS-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. | Procedure or surgery | EUS-GBD |
Primary outcome
Recurrence rate of cholecystitis within 24 months
Time frame: From the index intervention to 24 months after the index intervention
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.
Length of index hospital stay
Time frame: From hospital admission for acute cholecystitis to discharge from the index hospitalization, assessed up to 90 days
Duration of the index hospital stay, measured in days from hospital admission for acute cholecystitis to discharge from the index hospitalization.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCC and EUS-GBD in people with Acute Cholecystitis, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate of cholecystitis within 24 months (time frame: From the index intervention to 24 months after the index intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.