RecruitingACTRN12621000140853

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


Sponsor

St Vincent's Hospital Melbourne

Enrollment

20 participants

Start Date

Dec 9, 2020

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Acute pancreatitis — inflammation of the pancreas — can sometimes lead to a serious complication called "walled-off necrosis" (WON), where dead tissue becomes encased in a cyst-like fluid collection near the pancreas. This collection can become infected and cause life-threatening illness. The standard treatment is to drain the collection through a stent inserted during an endoscopy (a camera procedure through the mouth). This study is evaluating a recently approved stent called the Hot SPAXUS, used under endoscopic ultrasound guidance to drain these pancreatic fluid collections. While the stent is already available and approved, this Australian study is collecting data on how well it works and how safe it is in real-world clinical practice, which will add to the existing evidence from the USA, Korea, and Europe. Adults aged 18 or older who have symptomatic or infected pancreatic walled-off necrosis confirmed on MRI or CT, are fit for anaesthesia, and are able to provide consent may be eligible. Those who are pregnant, have severe blood-clotting problems, or whose collection does not meet certain criteria on endoscopic ultrasound are excluded. Participation means the collection would be drained with this specific stent as part of your care, with the team collecting follow-up data on your recovery.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 administera

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)

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

NSW,QLD,WA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,WA,VIC, Australia

Liverpool Hospital - Liverpool

NSW,QLD,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,WA,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

NSW,QLD,WA,VIC, Australia

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ACTRN12621000140853