The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.
The research design is a randomized prospective clinical trial comparing EUS-guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.The sample size estimated for this study is 60 patients. All patients will undergo EUS-guided drainage of WON and be randomized to either FCSEM or plastic stents in a 1:1 ratio using a computer-generated randomized sequence. It will not be possible to blind the endoscopist to the stent type being inserted due to the differences in stent appearance. The statistician will be blinded to the stent type utilized.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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Center for Interventional Endoscopy - Florida Hospital Orlando
Orlando, Florida, United States
Florida Hospital Center for Interventional Endoscopy
Orlando, Florida, United States
The number of interventions performed between metal and plastic stent groups to achieve treatment success
The primary objective of this study is to compare the number of interventions performed between metal and plastic stent groups to achieve treatment success at 6 week follow-up. Re-intervention is defined as the need for repeat EUS-guided drainage of WON using the same stent type and/or DEN and/or insertion of percutaneous catheter due to inadequate treatment response following initial WON drainage. As FCSEMS have larger diameter than plastic stents, the investigators hypothesize that the no. of re-interventions performed will be lower in the FCSEMS group compared to the plastic stent group.
Time frame: 6 weeks
Technical success
Successful deployment of transmural stents in to the WON cavity.
Time frame: at index treatment Day 0
Treatment success
Resolution of WON on CT scan and resolution of symptoms at 6-week outpatient follow-up (from day of hospital discharge) WITHOUT the need for cross-over to minimally invasive surgical debridement
Time frame: 6 week
Treatment failure
Need for minimally-invasive surgical debridement as a consequence of inadequate endoscopic treatment response, or death as a direct consequence of WON drainage or underlying diseaseor underlying disease.
Time frame: 6 months
Recurrence
Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
Time frame: 6 months
Procedure duration (minutes)
Time from start of the procedure (endoscope inserted into the gastrointestinal lumen to perform transmural drainage to the end of the procedure (removal of the echoendoscope/ gastroscope/ duodenoscope from the oropharynx).
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Time frame: at index treatment Day 0
Adverse events
Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
Time frame: 6 months
Duration of hospitalization
Day of procedure to the day of hospital discharge
Time frame: 6 months
Cost Analysis (Inpatient and outpatient costs)
Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
Time frame: 6 months