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Completed

NCT Number: NCT03525808

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

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%.

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Key information

Conditions

Walled Off Pancreatic Necrosis Digestive System Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Acute Necrotizing

Age range

22 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado, Denver, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AXIOS

Device

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 16, 2018
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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