Cholecystitis, AcuteEUSCAPENCT07792486
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
A study testing Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) and Percutaneous gallbladder drainage in people with Cholecystitis, Acute, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to learn if endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) works better than percutaneous gallbladder drainage (PT-GBD) for people with acute cholecystitis (inflammation of the gallbladder) who cannot undergo immediate surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) and Percutaneous gallbladder drainage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to 1 Oct 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years
- Definite diagnosis of acute cholecystitis following the Tokyo guidelines
- Poor surgical patients, not eligible for acute cholecystectomy according to their surgeon, with indication for gallbladder drainage.b The reason for ineligibility is recorded.
- Possibility to obtain written informed consent from the patient or their legal representative.
- Drainage with both modalities is technically feasible (i.e. the gallbladder can be accessed with both techniques), as assessed by the treating physician and/or expert panel.
Who cannot join
- Presence of a non-sealed perforated gallbladder. In case of a sealed perforation, patients can be included after assessment of an expert panel.
- Need of dual treatment with both modalities, already established beforehand.
- Prior gallbladder drainage attempts.
- Surgically altered anatomy (i.e. alterations to the oesophagus, stomach and duodenum).
- The presence of contraindications to either drainage modality, unless it is a temporary problem that can be mitigated beforehand (i.e. ascites drainage prior to percutaneous drainage).
- Permanently incapacitated and therefore inability to fill out the quality of life surveys.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC, location VUmc
Amsterdam, De Boelelaan 1118, 1081 HV
Willemijn JC van Dijk, MD, +31630572840, w.j.c.vandijk@amsterdamumc.nl
About this study
Official title: Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis: a Multicenter International Randomized Controlled Superiority Trial
The goal of this clinical trial is to learn if endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) works better than percutaneous gallbladder drainage (PT-GBD) for people with acute cholecystitis (inflammation of the gallbladder) who cannot undergo immediate surgery.
The main questions this study aims to answer are:
Read more
- Does EUS-GBD lead to fewer serious medical problems and fewer additional procedures within 30 days after treatment?
- Does EUS-GBD improve quality of life compared with PT-GBD?
Researchers will compare two methods of draining the gallbladder to see which treatment leads to better outcomes.
Participants will:
- Be randomly assigned to receive either EUS-GBD or PT-GBD.
- Receive gallbladder drainage performed by experienced specialists.
- Complete questionnaires about their health and quality of life before treatment and during follow-up.
- Have follow-up visits or telephone consultations at 7, 30, 182, and 365 days after the drainage procedure.
The study will include participants from hospitals in several (European) countries.
- Conditions
- Cholecystitis, Acute
- Being tested
- Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS), Percutaneous gallbladder drainage
- Keywords
- acute cholecystitis, Gallbladder drainage, EUS-GBD, PT-GBD
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS)Procedure or surgery
Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) via transduodenal route and with the direct technique using a cautery-enhanced LAMS with co-axial 7Fr 3-7 cm pigtail stent through the LAMS, and linear echo-endoscope.
- Absent gallbladder stones or stones <10mm: 10x10 mm stent
- Present gallbladder stones: 15x10 mm stent
Percutaneous gallbladder drainageProcedure or surgery
Percutaneous gallbladder drainage with Seldinger preferred technique using snographic and fluoroscopic guidance or cross-sectional imaging as needed. Preferred route is at the discretion of the interventional radiologist, as multiple recent studies have shown that transhepatic and transperitoneal approaches have similar outcomes. A needle according to physician preference may be used, with compatible guidewire, 8.5-10Fr pigtail catheter placed via an inter or subcostal approach.
| Study group | Role | What they receive |
|---|---|---|
| EUS-GBD | Experimental | The intervention group will receive transduodenal EUS-GBD with a lumen apposing metal stent (LAMS) with a co-axial pigtail stent placed through the LAMS. Receives: Procedure: Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) |
| PT-GBD | Other | The control group will receive standard treatment, i.e. PT-GBD. Receives: Procedure: Percutaneous gallbladder drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ideal 30-day outcome
The primary outcome is the ideal 30-day outcome, consisting of the absence of severe adverse events (AGREE grade ≥ II) and non-elective reinterventions for drainage or pancreato-biliary events.
Measured: 30 days after index drainage procedure
Health-related quality of life measured by the EQ-5D-5L
Health-related quality of life assessed using the EQ-5D-5L. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five response levels. Responses are converted to a single index value using a country-specific value set. Index values are anchored at 1 (full health) and 0 (a state equivalent to death), with negative values possible for states considered worse than death; higher index values indicate better health-related quality of life. Assessments at day 7 and day 30 will be combined into a single cumulative value; the exact value set and method of aggregation will be prespecified in the Statistical Analysis Plan.
Measured: At day 7 and 30 after index intervention
Quality of Life at day 7 and 30
Health-related quality of life assessed using the PROMIS Global-10 (Patient-Reported Outcomes Measurement Information System Global Health short form). Raw scores are converted to T-scores standardised to a mean of 50 and a standard deviation of 10 in the reference population; higher scores indicate better global physical and mental health. Assessments at day 7 and day 30 will be combined into a single cumulative value; the exact scoring and method of aggregation will be prespecified in the Statistical Analysis Plan.
Measured: At day 7 and 30 after index intervention
Secondary outcomes (8)
Individual components of the ideal 30-day outcome
Individual components of the primary outcome, including severe adverse events (AGREE grade ≥ II), all-cause mortality, and non-elective reinterventions for gallbladder drainage or pancreato-biliary events.
Measured: 30 days after drainage procedure
Technical and clinical success of gallbladder drainage
Technical success is defined as successful placement of the percutaneous drain or endoscopic stent during the index drainage procedure. Clinical success is defined as resolution of fever and improvement of symptoms related to acute cholecystitis. Resolution of fever is defined as body temperature below 38.0°C within 48 hours after the procedure.
Measured: During the index procedure and within 48 hours after drainage
Adverse events after gallbladder drainage
Occurrence of adverse events after gallbladder drainage graded according to the AGREE (Adverse events in GastRointEstinal Endoscopy) classification (Grade I-V).
Measured: 6 and 12 months after the drainage procedure
Number of reinterventions after gallbladder drainage
Number of endoscopic, radiological, or surgical reinterventions related to the previous gallbladder drainage procedure.
Measured: 12 months after the drainage procedure
Length of intensive care unit and hospital stay
Duration of intensive care unit (ICU) stay and total hospital stay in days, related and unrelated to cholecystitis.
Measured: From diagnosis until 12 months follow-up
Recurrent (pancreato-)biliary events
Number of recurrent (pancreato-)biliary events
Measured: 12 months after the drainage procedure
Mortality
All-cause mortality and mortality related to the drainage procedure or biliary events will be recorded.
Measured: 12 months after the drainage procedure
30 post-operative adverse events after interval cholecystectomy graded by AGREE classification
Proportion of patients undergoing interval cholecystectomy who experience one or more postoperative adverse events within 30 days after surgery, classified according to the AGREE (Adverse events in GastRointEstinal Endoscopy) classification (Grade I-V).
Measured: 30 days after interval cholecystectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- 212 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogier P. Voermans, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Rogier P Voermans, Gastroenterologist, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792486
- Sponsor's protocol ID
- NL-011026
- Acronym
- EUSCAPE
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis: a Multicenter International Randomized Controlled Superiority Trial
- ClinicalTrials.gov ID
- NCT07792486
- Acronym / sponsor ID
- EUSCAPE / NL-011026
- Conditions
- Cholecystitis, Acute
- Keywords
- acute cholecystitis, Gallbladder drainage, EUS-GBD, PT-GBD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 28 Aug 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.
The goal of this clinical trial is to learn if endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) works better than percutaneous gallbladder drainage (PT-GBD) for people with acute cholecystitis (inflammation of the gallbladder) who cannot undergo immediate surgery.
The main questions this study aims to answer are:
- Does EUS-GBD lead to fewer serious medical problems and fewer additional procedures within 30 days after treatment?
- Does EUS-GBD improve quality of life compared with PT-GBD?
Researchers will compare two methods of draining the gallbladder to see which treatment leads to better outcomes.
Participants will:
- Be randomly assigned to receive either EUS-GBD or PT-GBD.
- Receive gallbladder drainage performed by experienced specialists.
- Complete questionnaires about their health and quality of life before treatment and during follow-up.
- Have follow-up visits or telephone consultations at 7, 30, 182, and 365 days after the drainage procedure.
The study will include participants from hospitals in several (European) countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-GBD | Experimental | Procedure: Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS)The intervention group will receive transduodenal EUS-GBD with a lumen apposing metal stent (LAMS) with a co-axial pigtail stent placed through the LAMS. |
| PT-GBD | Other | Procedure: Percutaneous gallbladder drainageThe control group will receive standard treatment, i.e. PT-GBD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years
- Definite diagnosis of acute cholecystitis following the Tokyo guidelines
- Poor surgical patients, not eligible for acute cholecystectomy according to their surgeon, with indication for gallbladder drainage.b The reason for ineligibility is recorded.
- Possibility to obtain written informed consent from the patient or their legal representative.
- Drainage with both modalities is technically feasible (i.e. the gallbladder can be accessed with both techniques), as assessed by the treating physician and/or expert panel.
Key exclusion criteria (6 listed)
- Presence of a non-sealed perforated gallbladder. In case of a sealed perforation, patients can be included after assessment of an expert panel.
- Need of dual treatment with both modalities, already established beforehand.
- Prior gallbladder drainage attempts.
- Surgically altered anatomy (i.e. alterations to the oesophagus, stomach and duodenum).
- The presence of contraindications to either drainage modality, unless it is a temporary problem that can be mitigated beforehand (i.e. ascites drainage prior to percutaneous drainage).
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 |
|---|---|---|
| Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS)Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) via transduodenal route and with the direct technique using a cautery-enhanced LAMS with co-axial 7Fr 3-7 cm pigtail stent through the LAMS, and linear echo-endoscope. * Absent gallbladder stones or stones <10mm: 10x10 mm stent * Present gallbladder stones: 15x10 mm stent | Procedure or surgery | EUS-GBD |
| Percutaneous gallbladder drainagePercutaneous gallbladder drainage with Seldinger preferred technique using snographic and fluoroscopic guidance or cross-sectional imaging as needed. Preferred route is at the discretion of the interventional radiologist, as multiple recent studies have shown that transhepatic and transperitoneal approaches have similar outcomes. A needle according to physician preference may be used, with compatible guidewire, 8.5-10Fr pigtail catheter placed via an inter or subcostal approach. | Procedure or surgery | PT-GBD |
Primary outcome
Ideal 30-day outcome
Time frame: 30 days after index drainage procedure
The primary outcome is the ideal 30-day outcome, consisting of the absence of severe adverse events (AGREE grade ≥ II) and non-elective reinterventions for drainage or pancreato-biliary events.
Health-related quality of life measured by the EQ-5D-5L
Time frame: At day 7 and 30 after index intervention
Health-related quality of life assessed using the EQ-5D-5L. The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each with five response levels. Responses are converted to a single index value using a country-specific value set. Index values are anchored at 1 (full health) and 0 (a state equivalent to death), with negative values possible for states considered worse than death; higher index values indicate better health-related quality of life. Assessments at day 7 and day 30 will be combined into a single cumulative value; the exact value set and method of aggregation will be prespecified in the Statistical Analysis Plan.
Quality of Life at day 7 and 30
Time frame: At day 7 and 30 after index intervention
Health-related quality of life assessed using the PROMIS Global-10 (Patient-Reported Outcomes Measurement Information System Global Health short form). Raw scores are converted to T-scores standardised to a mean of 50 and a standard deviation of 10 in the reference population; higher scores indicate better global physical and mental health. Assessments at day 7 and day 30 will be combined into a single cumulative value; the exact scoring and method of aggregation will be prespecified in the Statistical Analysis Plan.
8 secondary outcomes
Individual components of the ideal 30-day outcome
Time frame: 30 days after drainage procedure
Technical and clinical success of gallbladder drainage
Time frame: During the index procedure and within 48 hours after drainage
Adverse events after gallbladder drainage
Time frame: 6 and 12 months after the drainage procedure
Number of reinterventions after gallbladder drainage
Time frame: 12 months after the drainage procedure
Length of intensive care unit and hospital stay
Time frame: From diagnosis until 12 months follow-up
Recurrent (pancreato-)biliary events
Time frame: 12 months after the drainage procedure
Mortality
Time frame: 12 months after the drainage procedure
30 post-operative adverse events after interval cholecystectomy graded by AGREE classification
Time frame: 30 days after interval cholecystectomy
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Rogier P Voermans, Gastroenterologist, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) and Percutaneous gallbladder drainage in people with Cholecystitis, Acute, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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: opening soon, as of the sponsor's last update on 29 Sep 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 Netherlands. 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?
Contact Willemijn JC van Dijk, MD (+31630572840, w.j.c.vandijk@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ideal 30-day outcome (time frame: 30 days after index drainage procedure). The study lists 3 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 29 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.