Cholecystitis, Acute
Conditions
Keywords
acute cholecystitis, Gallbladder drainage, EUS-GBD, PT-GBD
Brief 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. 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.
Interventions
PROCEDUREEndoscopic 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
PROCEDUREPercutaneous gallbladder drainage
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.
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ideal 30-day outcome | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Individual components of the ideal 30-day outcome | 30 days after drainage procedure | 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. |
| Technical and clinical success of gallbladder drainage | During the index procedure and within 48 hours after 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. |
| Adverse events after gallbladder drainage | 6 and 12 months after the drainage procedure | Occurrence of adverse events after gallbladder drainage graded according to the AGREE (Adverse events in GastRointEstinal Endoscopy) classification (Grade I-V). |
| Number of reinterventions after gallbladder drainage | 12 months after the drainage procedure | Number of endoscopic, radiological, or surgical reinterventions related to the previous gallbladder drainage procedure. |
| Length of intensive care unit and hospital stay | From diagnosis until 12 months follow-up | Duration of intensive care unit (ICU) stay and total hospital stay in days, related and unrelated to cholecystitis. |
| Recurrent (pancreato-)biliary events | 12 months after the drainage procedure | Number of recurrent (pancreato-)biliary events |
| Mortality | 12 months after the drainage procedure | All-cause mortality and mortality related to the drainage procedure or biliary events will be recorded. |
| 30 post-operative adverse events after interval cholecystectomy graded by AGREE classification | 30 days after interval cholecystectomy | 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). |
Countries
Netherlands
Contacts
CONTACTWillemijn JC van Dijk, MD
PRINCIPAL_INVESTIGATORRogier P Voermans, Gastroenterologist, MD, PhD
Amsterdam UMC
Outcome results
None listed