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

• ClinicalTrials.gov Identifier: NCT03525808
• Recruitment Status: Completed
• First Posted: May 16, 2018
• Results First Posted: December 20, 2021
• Last Update Posted: December 20, 2021
• Sponsor: Boston Scientific Corporation
• Information provided by (Responsible Party): Boston Scientific Corporation

Study Description

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%.

Condition or disease	Intervention/treatment	Phase
Walled Off Pancreatic Necrosis	Device: AXIOS	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents
• Actual Study Start Date: September 5, 2018
• Actual Primary Completion Date: March 31, 2020
• Actual Study Completion Date: October 2, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: AXIOS; Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.	Device: AXIOS; Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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 Outcome Measures :

1. Symptom Reduction [ Time Frame: Through study completion, average of 8 months ]
   Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
2. Technical Success [ Time Frame: 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.

3. Drainage Procedural Time [ Time Frame: Intraoperative (Stent placement) ]
   Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
4. Resolution of WON: Radiographic Resolution Evaluated by MRI or CT [ Time Frame: Through study completion, average of 8 months ]
   Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
5. Time to WON Resolution [ Time Frame: 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.
6. WON Recurrence [ Time Frame: Through study completion, average of 8 months ]
   Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
7. Stent Lumen Patency [ Time Frame: 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
8. Fluoroscopy [ Time Frame: Intraoperative (Stent placement through stent removal) ]
   Fluoroscopy (time) per endoscopic procedure.
9. Incidence of New Organ Failure [ Time Frame: Up to 60 days ]
   Number of participants with new organ failure from drainage procedure to WON resolution.
10. Change in SF-12 Score [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Colorado

University of Colorado, Denver

Aurora, Colorado, United States, 80045

United States, Georgia

Emory University Healthcare

Atlanta, Georgia, United States, 30322

United States, Indiana

Indiana University Health

Indianapolis, Indiana, United States, 46202

United States, Massachusetts

Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

• Principal Investigator: Barham K Abu Dayyeh, MD; Mayo Clinic

  Study Documents (Full-Text)

Documents provided by Boston Scientific Corporation:

Study Protocol  [PDF] August 16, 2018

Statistical Analysis Plan  [PDF] May 18, 2018

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Haddad MA, Sherman S, Merchant AA, Peetermans JA, Gjata O, McMullen E, Willingham FF. Combined Drainage and Protocolized Necrosectomy Through a Co-axial Lumen-Apposing Metal Stent for Pancreatic Walled-off Necrosis: A Prospective Multicenter Trial. Ann Surg. 2021 Nov 2. doi: 10.1097/SLA.0000000000005274. [Epub ahead of print]

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03525808
• Other Study ID Numbers: E7116
• First Posted: May 16, 2018
• Results First Posted: December 20, 2021
• Last Update Posted: December 20, 2021
• Last Verified: December 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Keywords provided by Boston Scientific Corporation:

Pancreatic necrosis

Additional relevant MeSH terms:

Pancreatitis, Acute Necrotizing; Necrosis; Pathologic Processes; Pancreatitis; Pancreatic Diseases; Digestive System Diseases