Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents
Pancreatic Necrosis
About this trial
This is an interventional treatment trial for Pancreatic Necrosis
Eligibility Criteria
Inclusion Criteria:
- Male or female between 18-80 years old (including patients aged 18 and 80)
- Subjects capable of giving informed consent
- Patients carrying the diagnosis or symptomatic sterile or infected walled-off pancreatic necrosis (WOPN) based upon Atlanta Classification (4) ≥ 4cm in largest diameter, deemed to require and amenable to endoscopic transmural drainage with or without necrosectomy by attending gastroenterologist
- Fluid collection size ≥ 4cm in largest diameter (based on CT, MRI, transabdominal or endoscopic ultrasound within 30days)
- Fluid collection that is adherent to the stomach/bowel wall allowing for fistula tract creation
- Fluid collection containing significant amount of necrotic material (defined as >30% of echogenic material by ultrasound/EUS, or necrotic debris by CT/MRI)
Exclusion Criteria:
- Inability to provide written informed consent
- Contraindications to endoscopic treatment as determined by the gastroenterologist attending
- Pregnant or nursing mothers
- Bleeding or coagulation disorder
- Previous surgical or endoscopic cystogastrostomy/enterostomy or necrosectomy
- Shock
- Cystic neoplasms or pancreatic malignancy
- Pseudocysts
- Subjects cannot be homeless or incarcerated
- Age younger than 18 or older than 80
- More than one pancreatic/peri-pancreatic fluid collection
Sites / Locations
- Dartmouth-Hitchcock Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
AXIOS™ stent
double pigtail stents
1. Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Repeat endoscopy will be performed for stent removal at or before 60 days at the discretion of the attending gastroenterologist
2. Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity. Necrosectomy will be performed at the discretion of the attending gastroenterologist. Routine repeat treating gastroenterologist for stent removal will not be necessary, but left to the discretion of the attending gastroenterologist.