Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis

NCT07792486 | Not Yet Recruiting DMC

• 1 other identifier: NL-011026
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystitis, Acute

Keywords

acute cholecystitis; Gallbladder drainage; EUS-GBD; PT-GBD

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  At day 7 and 30 after index intervention

Secondary Outcomes (8)

• Individual components of the ideal 30-day outcome

  30 days after drainage procedure

• Technical and clinical success of gallbladder drainage

  During the index procedure and within 48 hours after drainage

• Adverse events after gallbladder drainage

  6 and 12 months after the drainage procedure

• Number of reinterventions after gallbladder drainage

  12 months after the drainage procedure

• Length of intensive care unit and hospital stay

  From diagnosis until 12 months follow-up

Study Arms (2)

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.

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.

Procedure: Percutaneous gallbladder drainage

Interventions

Endoscopic ultrasound guided gallbladder drainage (EUS-GBD) with lumen apposing metal stents (LAMS) PROCEDURE

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

EUS-GBD

Percutaneous gallbladder drainage PROCEDURE

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.

PT-GBD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, De Boelelaan 1118, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Rogier P Voermans, Gastroenterologist, MD, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Willemijn JC van Dijk, MD

CONTACT

+31630572840; w.j.c.vandijk@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 28, 2026

Record last verified: 2026-07

Locations

NL (1)