Study of a Lumen- Apposing, Covered, Self-Expanding Metal Stent (Axios™) Versus Multiple Double Pigtail Stents
Stopped early · Not applicable
Conditions studied: Pancreatic Necrosis
In brief
The present study aims to compare the clinical efficacy and cost effectiveness of the AXIOS™ stent versus the "conventional" approach using double pigtail plastic stents in the treatment of patients with walled-off pancreatic necrosis.
Key facts
- Study ID
- NCT02673541
- Run by
- Dartmouth-Hitchcock Medical Center
- People needed
- 5
- Starts
- 2016-02-01
- Expected to finish
- 2017-12-18
- Last updated by the study team
- 2020-04-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
Full record on ClinicalTrials.gov
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