NCT03525808CompletedNot Applicable
A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
Boston Scientific Corporation10 sites in 1 country40 target enrollmentStarted: September 5, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 10
- Primary Endpoint
- Number of Participants With Resolution of WON With Endoscopic Drainage
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Number of Participants With Resolution of WON With Endoscopic Drainage
Time Frame: 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
Time Frame: Through study completion, average of 8 months
AXIOS stent related or WON drainage procedure related serious adverse events
Secondary Outcomes
- Technical Success(Intraoperative (Stent placement))
- Symptom Reduction(Through study completion, average of 8 months)
- Time to WON Resolution(Up to 60 Days)
- Stent Lumen Patency(Intraoperative (Stent placement through stent removal))
- Incidence of New Organ Failure(Up to 60 days)
- Resolution of WON: Radiographic Resolution Evaluated by MRI or CT(Through study completion, average of 8 months)
- Drainage Procedural Time(Intraoperative (Stent placement))
- WON Recurrence(Through study completion, average of 8 months)
- Fluoroscopy(Intraoperative (Stent placement through stent removal))
- Change in SF-12 Score(Difference from baseline to stent removal (up to 60 days) visit)
Investigators
Study Sites (10)
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