Randomized trial comparing direct endoscopic and transluminal interventions in necrotizing pancreatitis

Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic necrosis occurs as consequence of severe acute pancreatitis in approximately 20% of patients. While most collections resolve without intervention, a persistent collection causes pain, gastric outlet, intestinal or biliary obstruction, new-onset or persisting organ failure, persistent unwellness or infection, is associated with a mortality of 15-20% and requires treatment. Endoscopic management involves creation of a fistula by placement of a stent between the enteric wall and necrotic collection under the guidance of endoscopic ultrasound (EUS) to allow drainage of the necrotic material. In patients with suboptimal treatment outcomes, endoscopic necrosectomy may be warranted. This requires the additional technique of extraction of necrotic material under direct endoscopic visualization. However, there are currently scant data on the optimal timing of endoscopic necrosectomy.

Primary outcome: To compare clinical outcomes between patients undergoing direct endoscopic necrosectomy at index intervention versus step-up endoscopic approach (stent placement followed by endoscopic necrosectomy at subsequent intervention).

Inclusion criteria: Patients with suspected or proven infected necrotizing pancreatitis.

Study registration: ClinicalTrials.gov NCT05043415