Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON) (NCT05252897) | Clinical Trial Compass
RecruitingNot Applicable
Timing of Necrosectomy After Endoscopic Drainage of Walled-off Pancreatic Necrosis (WON)
Australia, Hong Kong, India108 participantsStarted 2022-02-01
Plain-language summary
Walled-off pancreatic necrosis (WON) is associated with a mortality of 20-30%. The current evidence supports a minimally invasive drainage approach to infected WON. The current suggested approach in international guidelines is the endoscopic step-up approach. However, recent evidence from large national cohorts support the use of direct endoscopic necrosectomy (DEN) at the time of stent placement, resulting in earlier resolution of WON and less number of necrosectomies. This study aims to investigate the clinical outcomes of the DEN versus the step-up approach for necrosectomy after endoscopic drainage of WON.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
A composite of major complications or death within 6 months after randomisation