Trial Outcomes & Findings for AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study (NCT NCT03525808)
NCT ID: NCT03525808
Last Updated: 2021-12-20
Results Overview
Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Up to 60 Days
Results posted on
2021-12-20
Participant Flow
Participant milestones
| Measure |
AXIOS Stent and Electrocautery Enhanced Delivery System
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were 2 participants whom were missing the SF-12 data.
Baseline characteristics by cohort
| Measure |
AXIOS Stent and Electrocautery Enhanced Delivery System
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
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Age, Customized
|
54.5 Years
STANDARD_DEVIATION 12.4 • n=40 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White (Caucasian)
|
35 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
|
Etiology of Acute Pancreatitis
Gallstones
|
22 Participants
n=40 Participants
|
|
Etiology of Acute Pancreatitis
Alcohol
|
4 Participants
n=40 Participants
|
|
Etiology of Acute Pancreatitis
ERCP
|
3 Participants
n=40 Participants
|
|
Etiology of Acute Pancreatitis
Hypertriglyceridemia
|
1 Participants
n=40 Participants
|
|
Etiology of Acute Pancreatitis
Lisinopril/Hydrochlorothiazide
|
1 Participants
n=40 Participants
|
|
Etiology of Acute Pancreatitis
Unknown
|
11 Participants
n=40 Participants
|
|
Severity of Acute Necrotizing Pancreatitis
Severe
|
21 Participants
n=40 Participants
|
|
Severity of Acute Necrotizing Pancreatitis
Moderately Severe
|
19 Participants
n=40 Participants
|
|
Baseline Imaging
Type of Imaging Used : Abdominal CT
|
28 participants
n=40 Participants
|
|
Baseline Imaging
Type of Imaging Used : MRI
|
12 participants
n=40 Participants
|
|
Baseline Imaging
Type of Imaging Used : EUS
|
4 participants
n=40 Participants
|
|
WON Symptom
Abdominal Pain
|
36 participants
n=40 Participants
|
|
WON Symptom
Weight Loss
|
23 participants
n=40 Participants
|
|
WON Symptom
Chronic Nausea
|
17 participants
n=40 Participants
|
|
WON Symptom
Leukocytosis
|
14 participants
n=40 Participants
|
|
WON Symptom
Lethargy
|
12 participants
n=40 Participants
|
|
WON Symptom
Deterioration of overall health score
|
14 participants
n=40 Participants
|
|
WON Symptom
Gastric Outlet Obstruction
|
10 participants
n=40 Participants
|
|
WON Symptom
Fever
|
7 participants
n=40 Participants
|
|
WON Symptom
Biliary Obstructive Symptoms
|
4 participants
n=40 Participants
|
|
WON Symptom
Systemic Inflammatory Response Syndrome
|
3 participants
n=40 Participants
|
|
WON Symptom
Deteriorating Organ Function
|
3 participants
n=40 Participants
|
|
Organ Failure, Affected Organ Systems
Respiratory
|
2 Participants
n=40 Participants
|
|
Organ Failure, Affected Organ Systems
Renal
|
3 Participants
n=40 Participants
|
|
Organ Failure, Affected Organ Systems
Cardiovascular
|
1 Participants
n=40 Participants
|
|
Organ Failure Score
0
|
36 Participants
n=40 Participants
|
|
Organ Failure Score
1
|
2 Participants
n=40 Participants
|
|
Organ Failure Score
2
|
1 Participants
n=40 Participants
|
|
Organ Failure Score
3
|
1 Participants
n=40 Participants
|
|
Organ Failure Score
4
|
0 Participants
n=40 Participants
|
|
Nutrition source/status
Non-Assisted Feeding/Non-Enteral Feeding
|
26 Participants
n=40 Participants
|
|
Nutrition source/status
Nasoduodenal/Nasojejunal
|
6 Participants
n=40 Participants
|
|
Nutrition source/status
Total Parenteral Nutrition
|
4 Participants
n=40 Participants
|
|
Nutrition source/status
Nasoenteric
|
2 Participants
n=40 Participants
|
|
Nutrition source/status
Nasogastric
|
1 Participants
n=40 Participants
|
|
Nutrition source/status
Percutaneous Endoscopic Gastrostomy
|
1 Participants
n=40 Participants
|
|
Nutrition source/status
Percutaneous Endoscopic Duodenostomy/Jejunostomy
|
0 Participants
n=40 Participants
|
|
SF-12 quality of life score
|
35.1 units on a scale
STANDARD_DEVIATION 19.5 • n=38 Participants • There were 2 participants whom were missing the SF-12 data.
|
PRIMARY outcome
Timeframe: Up to 60 DaysResolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Number of Participants With Resolution of WON With Endoscopic Drainage
|
39 Participants
|
PRIMARY outcome
Timeframe: Through study completion, average of 8 monthsAXIOS stent related or WON drainage procedure related serious adverse events
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
|
3 Participants
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SECONDARY outcome
Timeframe: Through study completion, average of 8 monthsReduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
Outcome measures
| Measure |
AXIOS
n=34 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
|
Symptom Reduction
|
29 Participants
|
SECONDARY outcome
Timeframe: Intraoperative (Stent placement)Technical AXIOS stent placement success, defined as placement in desired location using endoscopic/EUS techniques per standard of practice. Technical AXIOS stent removal success, defined as ability to remove the AXIOS stent using an endoscopic snare or forceps or graspers without AXIOS stent removal related serious adverse events.
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Technical Success
Placement Success
|
40 Participants
|
|
Technical Success
Removal Success
|
40 Participants
|
SECONDARY outcome
Timeframe: Intraoperative (Stent placement)Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
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Drainage Procedural Time
|
22.6 minutes
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: Through study completion, average of 8 monthsResolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Resolution of WON: Radiographic Resolution Evaluated by MRI or CT
|
40 Participants
|
SECONDARY outcome
Timeframe: Up to 60 DaysTime to WON resolution using same definition as for primary endpoint, namely: * Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI.
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Time to WON Resolution
|
34.1 days
Standard Deviation 16.8
|
SECONDARY outcome
Timeframe: Through study completion, average of 8 monthsRecurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
Outcome measures
| Measure |
AXIOS
n=34 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
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WON Recurrence
|
0 Participants
|
SECONDARY outcome
Timeframe: Intraoperative (Stent placement through stent removal)Stent lumen patency, evaluated via imaging or direct visual inspection with endoscope, and defined as one or both of the following: * Drainage through AXIOS stent visualized from the stomach or bowel, and/or * Visual confirmation of AXIOS stent lumen patency
Outcome measures
| Measure |
AXIOS
n=40 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Stent Lumen Patency
|
40 Participants
|
SECONDARY outcome
Timeframe: Intraoperative (Stent placement through stent removal)Fluoroscopy (time) per endoscopic procedure.
Outcome measures
| Measure |
AXIOS
n=38 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
|
Fluoroscopy
|
4.6 minutes
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: Up to 60 daysNumber of participants with new organ failure from drainage procedure to WON resolution.
Outcome measures
| Measure |
AXIOS
n=39 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Incidence of New Organ Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: Difference from baseline to stent removal (up to 60 days) visit\*Change\* in Quality of Life score (SF-12 questionnaire) from \*baseline to stent removal\*. The SF-12 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
Outcome measures
| Measure |
AXIOS
n=37 Participants
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Change in SF-12 Score
|
23.6 score on a scale
Standard Deviation 20.5
|
Adverse Events
AXIOS
Serious events: 19 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
AXIOS
n=40 participants at risk
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
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|---|---|
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Infections and infestations
Sepsis
|
12.5%
5/40 • Number of events 5 • From stent implant to 6-month post-stent removal
|
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Gastrointestinal disorders
Pancreatitis acute
|
5.0%
2/40 • Number of events 3 • From stent implant to 6-month post-stent removal
|
|
Gastrointestinal disorders
Pancreatitis
|
7.5%
3/40 • Number of events 3 • From stent implant to 6-month post-stent removal
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • Number of events 3 • From stent implant to 6-month post-stent removal
|
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General disorders
Complication associated with device
|
5.0%
2/40 • Number of events 2 • From stent implant to 6-month post-stent removal
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • Number of events 2 • From stent implant to 6-month post-stent removal
|
|
Infections and infestations
Bacteraemia
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
General disorders
Extravasation
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Vascular disorders
Shock
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Hepatobiliary disorders
Cholecystitis acute
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Infections and infestations
Gastrointestinal infection
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
General disorders
Chest pain
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Nervous system disorders
Monoplegia
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Renal and urinary disorders
Acute kidney injury
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Endocrine disorders
Hyperparathyroidism
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Gastrointestinal disorders
Pneumatosis intestinalis
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
2.5%
1/40 • Number of events 1 • From stent implant to 6-month post-stent removal
|
Other adverse events
| Measure |
AXIOS
n=40 participants at risk
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
AXIOS: Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
|
|---|---|
|
Infections and infestations
Localised infection
|
7.5%
3/40 • Number of events 3 • From stent implant to 6-month post-stent removal
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
5.0%
2/40 • Number of events 2 • From stent implant to 6-month post-stent removal
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place