None listed
Conditions
Brief 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.
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.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years old and over, and 2. Medically fit for anaesthesia, and 3. Pancreatic or peri-pancreatic walled off necrosis that is either symptomatic or infected, and 4. Imaging evidence of a WON on MRI or CT, and 5. Informed consent obtained from the patient or legal representative
Exclusion criteria
1. Aged under 18 years old 2. Pregnant at enrolment 3. Unable to obtain informed consent from the patient or legal representative 4. Medically unfit for anaesthesia 5. Asymptomatic collection 6. Irreversible coagulopathy: INR > 1.5 7. Irreversible thrombocytopenia: platelet count <50 x 109/L 8. Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure 9. WON secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury 10. Surgical or endoscopic necrosectomy or pseudocyst drainage that has been performed within the preceding 12 months 11. On EUS, located >10mm from GI lumen, immature wall, intervening vessel or structure, WON size <3cm, WON contains >80% solid necrosis
Outcome results
None listed