AXIOS Lumen Apposing Metal Stent for Walled Off Necrosis Drainage IDE Study
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|ClinicalTrials.gov Identifier: NCT03525808|
Recruitment Status : Completed
First Posted : May 16, 2018
Results First Posted : December 20, 2021
Last Update Posted : December 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Walled Off Pancreatic Necrosis||Device: AXIOS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Patients will receive the AXIOS stent for the treatment of walled-off pancreatic necrosis.
Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
- 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
- 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
- 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
- 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.
- Drainage Procedural Time [ Time Frame: Intraoperative (Stent placement) ]Time elapsed between initial puncture of the WON with electrocautery to endoscope retrieval.
- 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.
- 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.
- 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.
- 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
- Fluoroscopy [ Time Frame: Intraoperative (Stent placement through stent removal) ]Fluoroscopy (time) per endoscopic procedure.
- Incidence of New Organ Failure [ Time Frame: Up to 60 days ]Number of participants with new organ failure from drainage procedure to WON resolution.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525808
|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|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Barham K Abu Dayyeh, MD||Mayo Clinic|