Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Pancreatic Necrosis
About this trial
This is an interventional treatment trial for Pancreatic Necrosis focused on measuring walled off pancreatic necrosis, endoscopic drainage, direct endoscopic necrosectomy, endoscopic step up approach
Eligibility Criteria
Inclusion Criteria:
- Adult (≥18 years of age) patients
- Diagnosis of walled-off pancreatic necrosis (WON) based on imaging criteria based on the revised Atlanta classification5
- Documented history of acute pancreatitis
- Suspected or confirmed infected WON and/or symptomatic WON causing (i) persistent pancreatic-type pain, and/or ii) gastric outlet or biliary obstruction, and/or (iii) ongoing systemic illness, anorexia, and weight loss, and/or (iv) rapidly enlarging WONs, and/or (v) infected WON*
- WON identified at contrast-enhanced computed tomography (CECT) and deemed amenable for EUS-guided drainage
- WON with a solid component >30% and/ or percentage of necrosis >= 30%
Exclusion Criteria:
- Previous invasive interventions for necrotising pancreatitis
- An acute flare up of chronic pancreatitis
- Recurrent acute pancreatitis
- Indicated for emergency laparotomy (i.e. abdominal compartment syndrome, perforation of a visceral organ, bleeding and bowel ischaemia)
- Contraindications to endoscopic drainage: previous total gastrectomy, gastric bypass surgery, prior surgery for pancreas-related diseases
- WON not adherent to the GI wall or not accessible for endoscopic drainage
- Coagulopathy (INR >1.5), and/or thrombocytopenia (platelets <50,000/mm3)
- Pregnancy
Sites / Locations
- Royal Adelaide HospitalRecruiting
- The Chinese University of Hong KongRecruiting
- Medanta Institute Of Digestive & Hepatobiliary SciencesRecruiting
- Asian Institute of GastroenterologyRecruiting
- Deenanath Mangeshkar Hospital & Research CentreRecruiting
- Asan Medical CentreRecruiting
- SoonChunHyang University School of MedicineRecruiting
- Hospital Universitario Rio HortegaRecruiting
- King Chulalongkorn Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Endoscopic step-up approach
Direct endoscopic necrosectomy approach
After endoscopic drainage of WON, patients will be reassessed 72 hours after the procedure. If there is no clinical improvement 72 hours after drain placement, a CECT is performed to check the adequacy of the drainage. Irrigation of the WON via a nasocystic drain or endoscopic irrigation (step 1) is performed in case of inadequate drainage. If a nasocystic drain is inserted, 500ml of normal saline, twice a day will be used to irrigate the WON. If endoscopic irrigation is performed, only irrigation with normal saline without necrosectomy is allowed. Patients are again evaluated 72 hours after step 1. In case of improvement, treatment is conservative; otherwise step 2 will be initiated, which is endoscopic necrosectomy. Further endoscopic necrosectomy will be performed until there is clinical improvement.
Patients in the DEN group will undergo an immediate endoscopic necrosectomy after LAMS placement and balloon dilatation. A 10Fr 5cm double pigtail plastic stent will be inserted within the LAMS after necrosectomy. Patients will be assessed in 72 hours after the procedure. If there is no clinical improvement, a CECT is performed to check the adequacy of the drainage. DEN will be repeated in case of inadequate drainage. Patients will be reassessed every 72 hours and DEN repeated until there is clinical improvement. Subsequently, necrosectomy is performed weekly until a reassessment CECT at 3 weeks.