Health TrialsbyHealthPanel

Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage

ConditionAcute Cholecystitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOrlando Health, Inc.

About this trial

This is a randomized trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomized to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage. The aim of the study is to compare between these two treatment methods, the treatment outcomes and quality of life over a follow-up duration of 36 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines

Age ≥ 18 years

Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery.

Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement.

Disqualifiers

Pregnancy

Patients who are potential candidates for future cholecystectomy.

Patients unwilling to undergo follow-up assessments.

Patients with suspected gangrene or perforation of the gallbladder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Percutaneous cholecystostomy

    Procedure/Surgery

    Percutaneous cholecystostomy tube placement by interventional radiology

  • EUS-guided gallbladder drainage

    Procedure/Surgery

    EUS-guided gallbladder drainage using metal stent

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Percutaneous cholecystostomyActive comparator 1 intervention
Group B: EUS-guided gallbladder drainageActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events

A composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events, from index procedure to 36 months post-index intervention.

Time frame
36 months

Secondary outcomes

1

Mortality

Rate of mortality at 30 days post-index intervention due to underlying disease.

Time frame
30 days
2

Procedure-related adverse events

Rate of procedure-related adverse events, defined as adverse events resulting from the endoscopic or radiological procedures performed. Procedure-related adverse events will be graded according to Clavien-Dindo classification.

Time frame
36 months
3

Disease-related adverse events

Rate of disease-related adverse events, defined as adverse events resulting from underlying acute cholecystitis (such as gallbladder perforation, sepsis).

Time frame
36 months
4

New onset single and multiple organ failure.

Rate of new onset single and multiple organ failure.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Orlando Health, Inc.

Lead sponsor

Source ClinicalTrials.gov
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