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

Primary Purpose

Walled Off Pancreatic Necrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AXIOS
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Walled Off Pancreatic Necrosis focused on measuring Pancreatic necrosis

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado, Denver
  • Emory University Healthcare
  • Indiana University Health
  • Brigham & Women's Hospital
  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AXIOS

Arm Description

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

Outcomes

Primary Outcome Measures

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
AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
AXIOS stent related or WON drainage procedure related serious adverse events

Secondary Outcome Measures

Symptom Reduction
Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
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.
Drainage Procedural Time
Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
Resolution of WON: Radiographic Resolution Evaluated by MRI or CT
Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
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.
WON Recurrence
Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
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
Fluoroscopy
Fluoroscopy (time) per endoscopic procedure.
Incidence of New Organ Failure
Number of participants with new organ failure from drainage procedure to WON resolution.
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

Full Information

First Posted
April 13, 2018
Last Updated
December 17, 2021
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03525808
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
October 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Walled Off Pancreatic Necrosis
Keywords
Pancreatic necrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AXIOS
Arm Type
Experimental
Arm Description
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
Intervention Type
Device
Intervention Name(s)
AXIOS
Intervention Description
Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
Primary Outcome Measure Information:
Title
Number of Participants With Resolution of WON With Endoscopic Drainage
Description
Resolution of WON with endoscopic drainage defined as radiographic decrease of WON size to ≤ 3cm evaluated by CT scan or MRI
Time Frame
Up to 60 Days
Title
AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events
Description
AXIOS stent related or WON drainage procedure related serious adverse events
Time Frame
Through study completion, average of 8 months
Secondary Outcome Measure Information:
Title
Symptom Reduction
Description
Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4
Time Frame
Through study completion, average of 8 months
Title
Technical Success
Description
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.
Time Frame
Intraoperative (Stent placement)
Title
Drainage Procedural Time
Description
Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
Time Frame
Intraoperative (Stent placement)
Title
Resolution of WON: Radiographic Resolution Evaluated by MRI or CT
Description
Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.
Time Frame
Through study completion, average of 8 months
Title
Time to WON Resolution
Description
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.
Time Frame
Up to 60 Days
Title
WON Recurrence
Description
Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.
Time Frame
Through study completion, average of 8 months
Title
Stent Lumen Patency
Description
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
Time Frame
Intraoperative (Stent placement through stent removal)
Title
Fluoroscopy
Description
Fluoroscopy (time) per endoscopic procedure.
Time Frame
Intraoperative (Stent placement through stent removal)
Title
Incidence of New Organ Failure
Description
Number of participants with new organ failure from drainage procedure to WON resolution.
Time Frame
Up to 60 days
Title
Change in SF-12 Score
Description
*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
Time Frame
Difference from baseline to stent removal (up to 60 days) visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barham K Abu Dayyeh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Emory University Healthcare
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35129503
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, 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. Online ahead of print.
Results Reference
derived

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

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