An interventional study of Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) and Percutaneous gallbladder drainage in Cholecystitis, Acute, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Not applicable, Interventional, and Treatment
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:
Researchers will compare two methods of draining the gallbladder to see which treatment leads to better outcomes.
Participants will:
The study will include participants from hospitals in several (European) countries.
140 studies on the registry are indexed under Cholecystitis, Acute; 30 are open to participants now.
This study's planned enrollment of 212 is above the median of 90 across 84 interventional studies indexed under Cholecystitis, Acute.
Browse Cholecystitis, Acute studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 183 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS)
The control group will receive standard treatment, i.e. PT-GBD.
Procedure: Percutaneous gallbladder drainage
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 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: At day 7 and 30 after index intervention
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From diagnosis until 12 months follow-up
Recurrent (pancreato-)biliary events
Number of recurrent (pancreato-)biliary events
Time frame: 12 months after the drainage procedure
Mortality
All-cause mortality and mortality related to the drainage procedure or biliary events will be recorded.
Time frame: 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).
Time frame: 30 days after interval cholecystectomy
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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