NCT03767881CompletedNot Applicable
A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
Boston Scientific Corporation7 sites in 2 countries30 target enrollmentStarted: September 10, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 7
- Primary Endpoint
- Number of Days to Resolution of Acute Cholecystitis
Study Overview
Brief Summary
To evaluate the safety and effectiveness of the AXIOS™ Stent with Electrocautery Enhanced Delivery System in the management of symptoms of acute cholecystitis as an alternative to percutaneous gallbladder drainage.
Detailed Description
This study is a prospective, single arm, multi center trial. Treatment of up to 30 patients will take place at up to 9 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days indwell and 72 hour follow-up after stent removal.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient requiring intervention for the management of symptoms associated with acute cholecystitis
- •Patients referred for percutaneous drainage of the gallbladder who are not surgical candidates because of advanced age, anesthetic risk, significant co-morbidities and/or overall health
- •Eligible for endoscopic intervention
- •Acute Cholecystitis (AC) Grade I (mild) or II (moderate) per Tokyo guidelines:
- •AC Grade I (mild) defined as acute cholecystitis in an otherwise healthy patient with mild local inflammatory changes and without organ dysfunction. Criteria for grade II or III not met.
- •AC Grade II (moderate) defined by any one of the following characteristics
- •Leukocytosis (>18,000 cells per mm3)
- •Palpable, tender mass in right upper quadrant
- •Symptom duration >72 hours
- •Marked local inflammation (gangrenous or emphysematous cholecystitis, pericholecystic or hepatic abscess, biliary peritonitis)
- •Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion
- •18 years of age or older
- •Willing and able to comply with the study procedures and patient or legally authorized representative (LAR) must provide written informed consent form (ICF) to participate in the study
Exclusion Criteria
- •AC Grade III (severe) per Tokyo guidelines defined by organ dysfunction in any one of the following systems:
- •Cardiovascular - Hypotension requiring administration of ≥5μg/kg/min of dopamine or any dose of norepinephrine
- •Neurologic - decreased level of consciousness
- •Respiratory - PaO2/FiO2 <300
- •Renal - Oliguria and Creatinine >2.0 mg/dl (>177 μmol/liter)
- •Hepatic - International normalized ratio >1.5
- •Hematologic - Platelet count <100,000/mm3
- •Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder
- •Hepatic abscess
- •Patients with abnormal coagulation or who require ongoing complete anticoagulation
- •Bleeding diathesis
- •History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)
- •Patients with a current percutaneous drainage
- •Patients with a history of percutaneous gallbladder drainage without AC free period following percutaneous drainage removal
- •Distance between gallbladder wall and duodenal or gastric wall > 1cm by US (ultrasound) at the time of drainage
- •Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location
- •Patients that have allergies or are sensitive to any of the device materials
- •Patients with contraindications to use of electrical devices
- •Prisoners and other vulnerable populations
Arms & Interventions
AXIOS(TM) Stent and Electrocautery Enhanced Delivery System
Experimental
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
Intervention: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System (Device)
Outcomes
Primary Outcomes
Number of Days to Resolution of Acute Cholecystitis
Time Frame: Up to 15 weeks
Time to resolution of acute cholecystitis measured in days. Resolution is defined as either a fever of less than 100.5°F, or at least a 4-point decrease in the pain score, or WBC count less than 12,000/cc, with improvement in at least two of these categories without the deterioration of the third category.
Secondary Outcomes
- Rate of Re-interventions(Through study completion, Up to 15 weeks)
Investigators
Study Sites (7)
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