New Trial Investigates Strategic Timing of Endoscopic Interventions in Infected Necrotizing Pancreatitis

Clinical research investigators at Orlando Health Digestive Health Institute have initiated an international, multicenter, randomized clinical trial to formally evaluate the strategic timing of endoscopic procedural interventions in infected necrotizing pancreatitis (STEP-IN). Named the STEP-IN Trial, the study is in collaboration with participating centers across India, Germany, Italy, Denmark and four academic institutions within the United States.

Pancreatic necrosis complicates approximately 20%-30% of severe acute pancreatitis cases and can mature into a contained necrotic collection, typically four weeks into the disease course. While some necrotic collections can resolve without intervention, persistent symptomatic collections, especially if infected, can result in morbidity and mortality, requiring endoscopic interventions such as drainage and necrosectomy.

International guidelines based on traditional open surgical necrosectomy recommend delayed treatment in patients with suspected or confirmed infected necrotizing pancreatitis to allow for better necrosis demarcation and liquefaction. However, in clinical practice, many patients deteriorate before this window is reached.

“Prospective data from our institution and from recent meta-analysis suggest that interventions can be undertaken safely by adopting state-of-the-art endoscopic methods even when the onset of pancreatitis is less than four weeks,” says Shyam S. Varadarajulu, MD, president of Orlando Health Digestive Health Institute.

The STEP-IN Trial will formally evaluate if early interventions by highly skilled endoscopists using contemporary endoscopic methods such as EUS-guided transmural drainage can be performed safely within the first weeks of disease onset.

“In appropriately selected patients, early, minimally invasive endoscopic intervention may better prevent clinical deterioration, reduce complications, shorten hospital stay and decrease overall healthcare utilization compared with a delayed approach,” says Dr. Varadarajulu.

The research initiative is led by principal investigator Ji Young Bang, MD, director of clinical research and interventional endoscopist with Orlando Health Digestive Health Institute. Dr. Bang is assisted by clinical investigator Inge de Vries, a full-time MD, PhD scholar from the Netherlands. Dr. de Vries is working on her PhD in pancreatic biliary diseases as part of an international collaboration between Orlando Health and Amsterdam University Medical Center.

Orlando Health Digestive Health Institute is a referral center of excellence committed to furthering clinical research and clinician education. The institute’s internationally respected specialists address the most advanced, complex digestive disorders using comprehensive and coordinated tertiary care while also leading numerous studies testing next-generation interventions and contributing to international publications on gastroenterology and endoscopy.