Evaluation of the "Hot Spaxus" Lumen Apposing Stent for EUS-guided drainage of pancreatic walled off necrosis
Multicentre, Prospective Evaluation of the "Hot Spaxus" Lumen Apposing Stent for EUS-Guided Drainage of Pancreatic Walled Off Necrosis in Adults
St Vincent's Hospital Melbourne
20 participants
Dec 9, 2020
Interventional
Conditions
Summary
Acute pancreatitis can be complicated by local fluid collections in approximately 40% of cases. Sometimes these fluid collections contain necrotic debris (dead tissue), and are called walled off necrosis (WON). This can result in infection, pain, fevers or gastrointestinal upset. It can be life threatening without appropriate medical therapy. The primary treatment of pancreatic walled off necrosis is drainage of this collection into the stomach or duodenum (first part of the small bowel) using a stent inserted under endoscopic ultrasound (EUS) guidance. This study is being performed to assess the safety and effectiveness of a recently available TGA approved stent called the Hot SPAXUS stent. The Hot SPAXUS stent has been used for drainage of pancreatic fluid collections in the United States of America, Korea and parts of Europe. This research project is investigating its role in managing pancreatic WON collections in Australia, to provide further information on its use.
Eligibility
Plain Language Summary
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Interventions
Endoscopic ultrasound guided insertion of a fully covered lumen apposing stent (Hot SPAXUS) to drain symptomatic walled off necrosis. This intervention takes approximately 15 minutes. The administeration of the intervention will be performed by an expert interventional gastroenterologist in an endoscopy room or theatre room. The patient will be followed up at a minimum to assess clinical progress at 4 weeks and 3 months.
Locations(6)
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ACTRN12621000140853