Clinical trial NCT03525808: AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
Official title: A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Walled Off Pancreatic Necrosis
Keywords: Pancreatic necrosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Resolution of WON With Endoscopic Drainage
timeFrame: Up to 60 Days
measure: AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
timeFrame: Through study completion, average of 8 months
Secondary outcomes:
measure: Symptom Reduction
timeFrame: Through study completion, average of 8 months
measure: Technical Success
timeFrame: Intraoperative (Stent placement)
measure: Drainage Procedural Time
timeFrame: Intraoperative (Stent placement)
measure: Resolution of WON: Radiographic Resolution Evaluated by MRI or CT
timeFrame: Through study completion, average of 8 months
measure: Time to WON Resolution
timeFrame: Up to 60 Days
measure: WON Recurrence
timeFrame: Through study completion, average of 8 months
measure: Stent Lumen Patency
timeFrame: Intraoperative (Stent placement through stent removal)
measure: Fluoroscopy
timeFrame: Intraoperative (Stent placement through stent removal)
measure: Incidence of New Organ Failure
timeFrame: Up to 60 days
measure: Change in SF-12 Score
timeFrame: Difference from baseline to stent removal (up to 60 days) visit
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Atlanta
country: United States
facility: Emory University Healthcare
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Barham K Abu Dayyeh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dayyeh BKA, Chandrasekhara V, Shah RJ, Easler JJ, Storm AC, Topazian M, Levy MJ, Martin JA, Petersen BT, Takahashi N, Edmundowicz S, Hammad H, Wagh MS, Wani S, DeWitt J, Bick B, Gromski M, Al Haddad M, Sherman S, Merchant AA, Peetermans JA, Gjata O, McMullen E, Willingham FF. Combined Drainage and Protocolized Necrosectomy Through a Coaxial Lumen-apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial. Ann Surg. 2023 May 1;277(5):e1072-e1080. doi: 10.1097/SLA.0000000000005274. Epub 2023 Apr 6.