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

Cholecystitis, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03767881
• Other study ID #: E7108
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: December 2, 2021

Study information

• Verified date: November 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2, 2021
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven
United States	Emory University School of Medicine	Atlanta	Georgia
United States	University of Colorado Denver	Aurora	Colorado
United States	Cleveland Clinic	Cleveland	Ohio
United States	Parkview Medical Center	Fort Wayne	Indiana
United States	Mayo Clinic	Rochester	Minnesota
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	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)
Other	Acute Cholecystitis Recurrence	Recurrence of acute cholecystitis and its management post AXIOS stent removal	Through study completion, up to 15 weeks
Other	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
Primary	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	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