Necrosis of Pancreas, Infected Pancreatic Necrosis
Conditions
Keywords
symptomatic, infected, necrotic collection
Brief summary
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.
Detailed description
Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.
Interventions
PROCEDUREEndoscopic treatment
Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
PROCEDUREMinimally invasive surgical necrosectomy
Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.
Sponsors
AdventHealth
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Necrotic collection * Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents * Necrotic collection is within 15mm of the lumen of the gastrointestinal tract. * 18 years and older * Informed consent obtained from the patient or their medical representative. * Medically fit for general anesthetic * Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.
Exclusion criteria
* \<18 years old * Unable to obtain informed consent from the patient or their medical representative. * Medically unfit for general anesthesia * Pregnant * Necrotic collection not accessible by either or both techniques * The collection is \>15mm from the lumen of the gastrointestinal tract. * Irreversible coagulopathy: International Normalized Ratio (INR) \>1.5 * Irreversible thrombocytopenia: platelet count \<50 x10\^9/L * Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure * Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months * Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury. * Pre-existing percutaneous drain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major complications | 6 months post discharge | Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge |
Countries
United States
Outcome results
None listed