AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study

Not Applicable

Completed

Conditions: Walled Off Pancreatic Necrosis

Interventions: Device: AXIOS

Registration Number: NCT03525808

Lead Sponsor: Boston Scientific Corporation

Brief Summary: To demonstrate safety and effectiveness of lumen-apposing metal stents for resolution of walled off pancreatic necrosis (WONs) in patients with WONs with solid component \>30%.

Detailed Description: This study is a prospective, single arm, multi-center trial. Treatment of up to 40 patients will take place at up to 6 clinical centers. Patients who meet all eligibility criteria will receive the AXIOS stent for up to 60 days stent indwell and 6 months follow-up after stent removal.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age between 22 and 75 years old
Severe or moderately severe acute necrotizing pancreatitis, defined per the 2012 Revised Atlanta Classification.
WON resulting from necrotizing pancreatitis per contrast-enhanced CT with the following characteristics, per the 2012 Revised Atlanta Classification:
- Heterogeneous with liquid and non-liquid density with varying degrees of loculations (some may appear homogeneous)
- Well defined wall
- Location-intrapancreatic and/or extrapancreatic
Infected WON or symptomatic sterile WON Note: WON-related symptoms may include: pain, fever, leukocytosis, failure to thrive or deterioration of overall heath score, gastric outlet obstruction (GOO), weight loss, biliary obstructive symptoms, systemic inflammatory response syndrome (SIRS), deteriorating organ function, chronic nausea, lethargy, and inability to eat or gain weight
Imaging suggestive of greater than 30% necrotic material
WON ≥ 6cm in size
Eligible for endoscopic intervention
Acceptable candidate for endoscopic transluminal drainage
Patient understands the study requirements and the treatment procedures and provides written Informed Consent
Patient is willing to comply with all specified follow-up evaluations, including willingness to undergo a pre/post imaging study

Exclusion Criteria

Pseudocyst
Cystic neoplasm
Untreated Pseudoaneurysm > 1cm within the WON
More than one WON clearly separated and requiring drainage
WONs that require dual modality interventions (endoscopic and percutaneous) from the beginning (i.e. deep paracolic space involvement that is inaccessible through the central drainage access)
Prior surgical, interventional radiology or endoscopic procedures for the treatment of the WON
Abnormal coagulation:
- INR > 1.5 and not correctable
- presence of a bleeding disorder
- platelets < 50,000/mm3
Intervening gastric varices or unavoidable blood vessels within the access tract (visible using endoscopy or endoscopic ultrasound)
WON that poorly approximates the GI lumen (≥1cm away)
Pericolic gutter necrosis
Pelvic necrosis
Prior true anaphylactic reaction to contrast agents, nitinol (nickel titanium), silicone or any other materials contacting the patient
Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study
Currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AXIOS	AXIOS	Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Resolution of WON With Endoscopic Drainage	Up to 60 Days	Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI
AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events	Through study completion, average of 8 months	AXIOS stent related or WON drainage procedure related serious adverse events

Secondary Outcome Measures

Name	Time	Method
Technical Success	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.
Symptom Reduction	Through study completion, average of 8 months	Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
Time to WON Resolution	Up to 60 Days	Time 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.
Stent Lumen Patency	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
Incidence of New Organ Failure	Up to 60 days	Number of participants with new organ failure from drainage procedure to WON resolution.
Resolution of WON: Radiographic Resolution Evaluated by MRI or CT	Through study completion, average of 8 months	Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
Drainage Procedural Time	Intraoperative (Stent placement)	Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
WON Recurrence	Through study completion, average of 8 months	Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
Fluoroscopy	Intraoperative (Stent placement through stent removal)	Fluoroscopy (time) per endoscopic procedure.
Change in SF-12 Score	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

Trial Locations

Locations (5): Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Emory University Healthcare
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Atlanta, Georgia, United States
University of Colorado, Denver
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Aurora, Colorado, United States
Indiana University Health
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Indianapolis, Indiana, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States