Comparison of FCSEMS and Plastic Stents (WON-MVP)
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|ClinicalTrials.gov Identifier: NCT02685865|
Recruitment Status : Completed
First Posted : February 19, 2016
Last Update Posted : February 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infected Pancreatic Necrosis Acute Pancreatic Fluid Collection Pancreatic and Peripancreatic Necrosis Pancreatic Collection Symptomatic Pancreatic Necrosis||Device: FCSEM Stent Device: Plastic Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis|
|Actual Study Start Date :||February 12, 2016|
|Actual Primary Completion Date :||July 10, 2018|
|Actual Study Completion Date :||August 2018|
Active Comparator: FCSEM Stent
WON is first identified using EUS and punctured using a 19 gauge needle. 10 ml of fluid is aspirated and sent for gram stain and culture with sensitivities. Using a catheter-based stent delivery system with a 15mm AXIOS stent mounted onto it is inserted into the echoendoscope, and introduced into the WON cavity so that the stent lies within both the WON and enteric lumen. The stent is then deployed so that one flange of the stent is located within the WON cavity and the other flange is located within the enteric lumen.
Device: FCSEM Stent
Hot Axios Fully covered self-expandable metal stent - Boston Scientific
Other Name: Fully covered self-expandable metal stent
Active Comparator: Plastic Stents
WON is first identified using EUS, and punctured using a 19 gauge needle. 10 ml of the WON fluid is aspirated and sent for gram stain and culture with sensitivities. A 0.025 or 0.035 inch guidewire is inserted into the WON through the fine needle aspiration (FNA) needle. A transmural tract is created using an Endoscopic Retrograde Cholangiopancreatography(ERCP) catheter (with the use of a needle knife catheter ± cautery if needed), and then dilated using a 12-13.5-15mm Controlled Radial Expansion (CRE) balloon to a maximum size of 15mm if technically possible. Two or three 7 French plastic stents are inserted through the transmural tract into the WON cavity.
Device: Plastic Stent
7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific
- The number of interventions performed between metal and plastic stent groups to achieve treatment success [ Time Frame: 6 weeks ]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.
- Technical success [ Time Frame: at index treatment Day 0 ]Successful deployment of transmural stents in to the WON cavity.
- Treatment success [ Time Frame: 6 week ]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
- Treatment failure [ Time Frame: 6 months ]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.
- Recurrence [ Time Frame: 6 months ]Development of WON or additional Pancreatic Fluid Collection and recurrence of symptoms following initial treatment success
- Procedure duration (minutes) [ Time Frame: at index treatment Day 0 ]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).
- Adverse events [ Time Frame: 6 months ]Adverse event directly resulting from performing endoscopic drainage procedure. The severity will be graded according to a previously published consensus.
- Duration of hospitalization [ Time Frame: 6 months ]Day of procedure to the day of hospital discharge
- Cost Analysis (Inpatient and outpatient costs) [ Time Frame: 6 months ]Inpatient and outpatient costs of care will be calculated based on Medicare reimbursement fee structure.
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): NCT02685865
|United States, Florida|
|Center for Interventional Endoscopy - Florida Hospital Orlando|
|Orlando, Florida, United States, 32803|
|Florida Hospital Center for Interventional Endoscopy|
|Orlando, Florida, United States, 32803|
|Principal Investigator:||Shyam Varadarajulu, MD||Florida Hospital Orlando|