Plastic Stents vs. NAGI Bi-flanged Metal Stent for Endoscopic Ultrasound Guided Drainage of Walled-off Necrosis
Acute Necrotizing Pancreatitis, Walled Off Necrosis
About this trial
This is an interventional treatment trial for Acute Necrotizing Pancreatitis
Eligibility Criteria
Inclusion Criteria:
- Adult >18 years,
- Patient with symptomatic WON
- Debris <50% (based on cross sectional imaging)
- Written informed consent
Exclusion Criteria:
- Pregnancy or breast feeding,
- Severe coagulopathy INR >1.5 which is not correctable and/or platelets <50000/mm3
- Endoscopic drainage is technically not feasible
- Fluid collections other than WON
- Patient who is unable to understand study protocol or not willing for follow-up requirements
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
NAGI bi-flanged metal stent (BFMS)
Plastic stents
The WON will be punctured using a standard 19-gauge FNA needle and the aspirate was sent for biochemical and microbial analysis. A 0.025-inch (Visiglide; Olympus Corporation, Tokyo, Japan) or 0.035-inch stiff guidewire (Jag Wire; Boston Scientific) passed through the needle into the cyst cavity to form at least 1 to 2 loops under fluoroscopic guidance. A 6F cystotome (Endo-flex GmbH Dusseldorf, Germany) will be passed over the guidewire for creating a fistula. Subsequently, a 6-mm balloon dilator (Hurricane; Boston Scientific Corporation or Titan balloon, Wilson Cook) will be used to further dilate the fistula tract. After this, the stent delivery catheter is advanced over the guidewire across the PFC wall and the BFMS (Nagi; Taewoong Medical, Gyeonggi-do, South Korea) deployed using sonographic, fluoroscopic and endoscopic visualization.
Double-pigtail plastic stents will be used. A minimum of one 10Fr pigtail plastic stent will be placed. After initial EUS-guided access, the ostomy will be dilated first, using a cystotome, and secondly with a balloon dilation. The plastic stent will be inserted and delivered following the routine technique of each interventional endoscopist. The number of the plastic stents and the size of the balloon used to dilate the ostomy will depend on the WON size and content.