Clinical trial NCT03767881: AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE
Official title: A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis, Acute
Keywords: AXIOS
Acute Cholecystitis
Percutaneous Gallbladder Drainage
Cholecystitis
Gallbladder Drainage
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Patient requiring intervention for the management of symptoms associated with acute cholecystitis
2. 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
3. Eligible for endoscopic intervention
4. 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)
5. Pre-drainage imaging confirms sufficient stone-free space to allow AXIOS™ stent deployment and complete flange expansion
6. 18 years of age or older
7. 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:

1. 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
2. Obvious signs on diagnostic imaging of perforated, extensive gangrenous or ischemic gallbladder
3. Hepatic abscess
4. Ascites
5. Patients with abnormal coagulation or who require ongoing complete anticoagulation
6. Bleeding diathesis
7. History of surgical treatment of acute cholecystitis (e.g. cholecystectomy)
8. Patients with a current percutaneous drainage
9. Patients with a history of percutaneous gallbladder drainage without AC free period following percutaneous drainage removal
10. Distance between gallbladder wall and duodenal or gastric wall \> 1cm by US (ultrasound) at the time of drainage
11. Patients with intervening gastric varices or vessels within a one centimeter radius of the device insertion location
12. Patients that have allergies or are sensitive to any of the device materials
13. Patients with contraindications to use of electrical devices
14. Pregnancy
15. Prisoners and other vulnerable populations

Primary outcomes:
measure: Number of Days to Resolution of Acute Cholecystitis
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Rate of Re-interventions
timeFrame: Through study completion, Up to 15 weeks
Other outcomes:
measure: Stent Patency
timeFrame: Stent placement through stent removal, approximately 60 days
measure: Number of Participants With Successful Technical Stent Placement.
timeFrame: Intraoperative (stent placement)
measure: Number of Participants With Successful Technical Stent Removal.
timeFrame: Intraoperative (stent removal)
measure: Acute Cholecystitis Recurrence
timeFrame: Through study completion, up to 15 weeks
measure: Number of Cumulative Hospital and ICU Days
timeFrame: Through study completion, up to 15 weeks
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Fort Wayne
country: United States
facility: Parkview Medical Center
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Virginia Mason Medical Center
name: Shayan Irani, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: