Cholecystitis, Acute
Conditions
Keywords
AXIOS, Acute Cholecystitis, Percutaneous Gallbladder Drainage, Cholecystitis, Gallbladder Drainage
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.
Interventions
Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days to Resolution of Acute Cholecystitis | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Re-interventions | Through study completion, Up to 15 weeks | Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Technical Stent Removal. | Intraoperative (stent removal) | Technical stent removal success, defined as the ability to remove the AXIOS stent endoscopically without stent removal related serious adverse events |
| Stent Patency | Stent placement through stent removal, approximately 60 days | 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 |
| Number of Cumulative Hospital and ICU Days | Through study completion, up to 15 weeks | Number of cumulative hospital and ICU days from initial stent placement to resolution of symptoms of acute cholecystitis |
| Acute Cholecystitis Recurrence | Through study completion, up to 15 weeks | Recurrence of acute cholecystitis and its management post AXIOS stent removal |
| Number of Participants With Successful Technical Stent Placement. | Intraoperative (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 |
Countries
Belgium, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AXIOS Stent and Electrocautery Enhanced Delivery System Patients will receive the AXIOS stent for the treatment of
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | AXIOS Stent and Electrocautery Enhanced Delivery System |
|---|---|
| Age, Continuous | 75.2 Years STANDARD_DEVIATION 14.1 |
| BMI | 26.9 kg/m² STANDARD_DEVIATION 6.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 168.6 cm STANDARD_DEVIATION 9.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment Belgium | 10 participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 19 Participants |
| Weight | 76.4 kg STANDARD_DEVIATION 17.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 30 |
| other Total, other adverse events | 22 / 30 |
| serious Total, serious adverse events | 16 / 30 |
Outcome results
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.
Time frame: Up to 15 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Number of Days to Resolution of Acute Cholecystitis | 5.30 days | Standard Deviation 14.9 |
t-test, 1 sided
Secondary
Rate of Re-interventions
Rate of re-interventions including but not limited to stent migration, stent occlusion by GB stones, and luminal debridement.
Time frame: Through study completion, Up to 15 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Rate of Re-interventions | 5 Participants |
1-sided Clopper-Pearson 99.7% CI
Other Pre-specified
Acute Cholecystitis Recurrence
Recurrence of acute cholecystitis and its management post AXIOS stent removal
Time frame: Through study completion, up to 15 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Acute Cholecystitis Recurrence | 3 Participants |
Other Pre-specified
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
Time frame: Through study completion, up to 15 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Number of Cumulative Hospital and ICU Days | 8.30 Days | Standard Deviation 7.14 |
Other Pre-specified
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
Time frame: Intraoperative (stent placement)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Number of Participants With Successful Technical Stent Placement. | 28 Participants |
Other Pre-specified
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
Time frame: Intraoperative (stent removal)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Number of Participants With Successful Technical Stent Removal. | 19 Participants |
Other Pre-specified
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
Time frame: Stent placement through stent removal, approximately 60 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AXIOS(TM) Stent and Electrocautery Enhanced Delivery System | Stent Patency | 22 Participants |