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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents

Conditions
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Walled Off Pancreatic Necrosis

Intervention / Treatment
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* Device: AXIOS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AXIOS<br>Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis. | Device: AXIOS<br>* Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic necrosis