A Randomized Controlled Trial to Evaluate the Efficacy of Immobilized Lipase (RELiZORB) During Enteral Nutrition in Patients With Exocrine Pancreatic Insufficiency Secondary to Acute Pancreatitis

What this Trial Is About

Researchers are evaluating the use of RELiZORB, an immobilized lipase device, to improve management of exocrine pancreatic insufficiency (EPI) in patients who require feeding tube support after pancreatitis. Pancreatitis is a painful inflammation of the pancreas that can lead to EPI, where the pancreas does not produce enough enzymes to digest food properly. Although pancreatic enzyme replacement therapy (PERT) is commonly used for EPI, it can be difficult for patients relying on feeding tubes. This study aims to assess RELiZORB's effectiveness in this specific patient group, as previous research focused on cystic fibrosis patients. Participants will be randomly assigned to one of two groups: one receiving tube feeds via nasogastric or nasojejunal tubes without RELiZORB, and the other receiving tube feeds with RELiZORB. RELiZORB is a single-use cartridge that connects to feeding tubes and helps break down fats in enteral formulas to aid absorption. The study will last for 14 days from randomization for the primary outcome, with additional follow-up assessments up to 90 days. During the study, participants will complete the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at 14 days. Other evaluations include time to treatment failure, biochemical profiles, stool assessments at 30, 60, and 90 days, and time to resume oral nutrition within 90 days. Researchers will monitor the participants’ response to treatment and safety throughout the study, which is sponsored by Massachusetts General Hospital and planned to run through July 2027.

Evaluating the Efficacy of RELiZORB in Managing Exocrine Pancreatic Insufficiency in Tube-fed Pancreatitis Patients