AXIOS™ for Gallbladder Drainage as an Alternative to Percutaneous Drainage IDE

A Multicenter, Prospective Study of EUS-Guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis as an Alternative to Percutaneous Gallbladder Drainage

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.

Study Overview

• Status: Completed
• Conditions: Cholecystitis, Acute
• Intervention / Treatment: Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • UZ Leuven
• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University School of Medicine
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Washington
    • Seattle, Washington, United States, 98101
      • Virginia Mason Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System; Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.	Device: AXIOS(TM) Stent and Electrocautery Enhanced Delivery System; Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days to Resolution of Acute Cholecystitis	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.	Up to 15 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Re-interventions	Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.	Through study completion, Up to 15 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent Patency	Stent patency (ability to facilitate gallbladder drainage) defined indirectly as resolution of acute cholecystitis or, in the absence of resolution of acute cholecystitis, endoscopic observation of unobstructed AXIOSTM stent lumen	Stent placement through stent removal, approximately 60 days
Number of Participants With Successful Technical Stent Placement.	Technical AXIOS stent placement success, defined as transmural placement of the AXIOSTM stent with confirmed stent patency via (i) drainage visualized through the stent or fluoroscopically, or (ii) ability to endoscopically observe the inner walls of the gallbladder through the AXIOSTM stent	Intraoperative (stent placement)
Number of Participants With Successful Technical Stent Removal.	Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events	Intraoperative (stent removal)
Acute Cholecystitis Recurrence	Recurrence of acute cholecystitis and its management post AXIOS stent removal	Through study completion, up to 15 weeks
Number of Cumulative Hospital and ICU Days	Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis	Through study completion, up to 15 weeks

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Shayan Irani, MBBS, MD, Virginia Mason Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): December 2, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 5, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cholecystitis; Acute Cholecystitis; AXIOS; Percutaneous Gallbladder Drainage; Gallbladder Drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Gallbladder Diseases; Biliary Tract Diseases; Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
• Other Study ID Numbers: E7108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes