In this multicenter, randomized controlled trial, patients with pancreatic walled-off necrosis (WON) based on inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either receive intravenous infusion or oral administration of continuous proton pump inhibitors (PPIs) or to undergo no PPI (nPPI) therapy after endoscopic ultrasound-guided transluminal drainage/debridement. Clinical data and patient-reported outcomes will be systematically collected at baseline and during follow-up periods. The study aims to assess whether PPI use after EUS-TD (Endoscopic Ultrasonography-Guided Transmural Drainage) increases the number of direct endoscopic necrosectomies required to managing WON. Additionally, the study will investigate the impact of PPI use on the incidence of stent occlusion and postoperative complications following EUS-TD, as well as its effect on the average duration of hospitalization and associated costs for patients with WON.
Patients aged 18 years or older and not exceeding 80 years of age.
Patients with a confirmed diagnosis of WON.
Patients requiring endoscopic ultrasound-guided transluminal drainage/debridement therapy.
Patients who have signed informed consent forms.
Patients diagnosed with chronic pancreatitis who have not experienced an acute pancreatitis attack within the past three months.
Patients with severe coagulation disorders (International Normalized Ratio [INR] > 1.5).
Patients with significant thrombocytopenia (platelet count < 50 × 10^9/L).
Pregnant women.
Parallel
Proton Pump Inhibitors
DrugOn the day of endoscopic ultrasound-guided transluminal drainage/debridement, patients initiated proton pump inhibitor therapy via intravenous infusion or oral administration.
Total number of interventions
The total number of endoscopic interventions required to achieve successful WON treatment, including reinterventions, stents removal, and any other interventions performed during the 6-month follow-up period to manage adverse events or disease-specific events.
Technical Success Rate
Successfully placed stents to drain WON.
Clinical success rate
The lesion size has decreased by more than 50% compared to preoperative measurements, with concurrent symptom relief. No further intervention is required prior to stents removal.
Stent occlusion rate
The stent lumen is obstructed by necrotic tissue, debris, or blood clots, leading to impaired drainage and necessitating reintervention, such as stent replacement or direct endoscopic necrosectomy.
Hospitalization and cost
The hospitalization duration, ICU stay duration, and hospitalization costs related to WON treatment
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Qilu Hospital of Shandong University
Lead sponsor
960th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Collaborator
Shandong Provincial Hospital
Collaborator
Shengli Oilfield Hospital
Collaborator
Shenzhen People's Hospital
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
