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Walled Off Pancreatic NecrosisNCT03525808

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

A study testing AXIOS in people with Walled Off Pancreatic Necrosis, run by Boston Scientific Corporation at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Ages 22 to 75 years
Conditions the study is for
Walled Off Pancreatic Necrosis
What is being tested?
AXIOS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesUnited States
Study dates
5 Sep 2018to 2 Oct 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Emory University Healthcare

    Atlanta, Georgia, 30322

  • University of Colorado, Denver

    Aurora, Colorado, 80045

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115

  • Indiana University Health

    Indianapolis, Indiana, 46202

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Multicenter, Single-arm Study of Endoscopic Ultrasound-Guided Drainage of Walled-off Pancreatic Necrosis With Lumen-Apposing Metal Stents

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%.

Read the 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.

Being tested
AXIOS
Keywords
Pancreatic necrosis
Medical subject headings
Pancreatitis, Acute Necrotizing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AXIOSDevice

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

Study groups in NCT03525808
Study groupRoleWhat they receive
AXIOSExperimentalPatients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
Receives: Device: AXIOS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 60 Days

  2. AXIOS Stent Related or WON Drainage Procedure Related Serious Adverse Events

    AXIOS stent related or WON drainage procedure related serious adverse events

    Measured: Through study completion, average of 8 months

Secondary outcomes (10)

  1. Symptom Reduction

    Reduction of WON-related clinical symptoms. Note: WON-related symptoms as defined in Inclusion Criteria #4

    Measured: Through study completion, average of 8 months

  2. 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.

    Measured: Intraoperative (Stent placement)

  3. Drainage Procedural Time

    Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.

    Measured: Intraoperative (Stent placement)

  4. Resolution of WON: Radiographic Resolution Evaluated by MRI or CT

    Resolution of WON with or without necrosectomy by 6 months post AXIOS stent removal.

    Measured: Through study completion, average of 8 months

  5. 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.

    Measured: Up to 60 Days

  6. WON Recurrence

    Recurrence of WON after initial resolution and up to 6 months post AXIOS stent removal.

    Measured: Through study completion, average of 8 months

  7. 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

    Measured: Intraoperative (Stent placement through stent removal)

  8. Fluoroscopy

    Fluoroscopy (time) per endoscopic procedure.

    Measured: Intraoperative (Stent placement through stent removal)

  9. Incidence of New Organ Failure

    Number of participants with new organ failure from drainage procedure to WON resolution.

    Measured: Up to 60 days

  10. 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

    Measured: Difference from baseline to stent removal (up to 60 days) visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study start5 Sep 2018
  3. Primary completion31 Mar 2020
  4. Study completion2 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03525808
Sponsor's protocol ID
E7116
Status last verified
Dec 2021
First submitted
13 Apr 2018
Last updated
20 Dec 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 35129503

Questions about this trial

What is this clinical trial studying?

A study testing AXIOS in people with Walled Off Pancreatic Necrosis, run by Boston Scientific Corporation at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Resolution of WON With Endoscopic Drainage (time frame: Up to 60 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03525808, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.

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