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

NCT ID: NCT03525808

Last Updated: 2021-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2020-10-02

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.

Conditions

Walled Off Pancreatic Necrosis

Keywords

Pancreatic necrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AXIOS

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

Group Type: EXPERIMENTAL

AXIOS

Intervention Type: DEVICE

Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.

Interventions

AXIOS

Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barham K Abu Dayyeh, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

University of Colorado, Denver

Aurora, Colorado, United States

Emory University Healthcare

Atlanta, Georgia, United States

Indiana University Health

Indianapolis, Indiana, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35129503 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

E7116

Identifier Type: -

Identifier Source: org_study_id