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

Purpose

This research aims to improve the management of exocrine pancreatic insufficiency (EPI), a condition that can develop after pancreatitis, a painful inflammation of the pancreas. EPI occurs when the pancreas does not produce enough enzymes to help the body properly digest food. While pancreatic enzyme replacement therapy (PERT) is commonly used to manage EPI symptoms, it can be challenging for people who rely on feeding tubes. RELiZORB, could help these patients by simplifying the delivery of the enzymes they need. However, RELiZORB has only been studied in people with EPI caused by cystic fibrosis, so its effectiveness in pancreatitis patients remains unknown. This study aims to determine whether RELiZORB is effective for individuals requiring feeding tube support after pancreatitis.

Conditions

  • Exocrine Pancreatic Insufficiency (EPI)
  • Pancreatitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient diagnosed with moderate or severe exocrine pancreatic insufficiency (EPI), as defined using the Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) symptom score of 1.4 or greater. - Patient diagnosed with acute, recurrent acute pancreatitis or subacute pancreatitis. Subacute pancreatitis is defined as recent diagnosis of acute pancreatitis with sequelae of the acute episode including infection, pseudocyst, walled-off pancreatic necrosis. - Patient is currently admitted to the hospital at the time of study enrollment. - Patient requiring at least 50% of daily caloric and fluid intake through enteral tube feeds. - Patient is able and willing to provide informed consent.

Exclusion Criteria

  • Patient with chronic pancreatitis - Patient is currently intubated and unable to provide consent - Patient with active gastrointestinal tract cancer - Patient requiring less than 50% of nutritional support at time of enrollment - Patient is unable to tolerate any form of enteral nutrition

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
No RELiZORB 		Patients will receive tube feeds (via nasogastric or nasojejunal tube) without the use of RELiZORB
Experimental
RELiZORB 		Patients will receive tube feeds (via nasogastric or nasojejunal tube) with the use of RELiZORB
  • Device: RELiZORB
    RELiZORB (immobilized lipase) is a therapeutic device designed to enhance fat absorption in patients receiving enteral tube feedings. It works by hydrolyzing fats found in enteral formulas. RELiZORB is a single-use cartridge that connects in-line with enteral feeding sets. It contains lipase covalently bound to small polymer beads, forming a complex called iLipase, which remains within the cartridge. As the enteral formula passes through the cartridge, its fat content is hydrolyzed upon contact with iLipase. This process is especially beneficial for the absorption of long-chain polyunsaturated fatty acids, which require hydrolysis by pancreatic lipase for proper intestinal absorption. RELiZORB is compatible with a wide variety of commercially available enteral formulas.
    Other names:
    • Immobilized Lipase

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Casey M Luckhurst, MD
617-726-2760
cluckhurst@mgb.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Casey M Luckhurst, MD
617-726-2760
cluckhurst@mgb.org

Detailed Description

Acute pancreatitis remains one of the leading gastrointestinal causes of hospital admission in the United States. While most cases of pancreatitis are mild and resolve without further complications, approximately 20% progress to necrotizing pancreatitis, and 10% may develop chronic pancreatitis. Although significant attention has been given to the acute management of necrotizing pancreatitis, there is a growing focus on diagnosing and managing the long-term complications of pancreatitis. Exocrine pancreatic insufficiency (EPI) is a known complication following acute pancreatitis, with even higher rates observed in cases of necrotizing pancreatitis and chronic pancreatitis. Diagnosing and managing EPI is critical, as it has significant implications for patient outcomes and mortality. Despite this, EPI remains underdiagnosed, prompting the publication of multiple guidelines aimed at improving its diagnosis and treatment. The standard treatment for EPI is oral pancreatic enzyme replacement therapy (PERT). While PERT regimens have proven effective, their use in patients requiring tube feeding is often impractical. Immobilized lipase (RELiZORB) offers potential advantages for patients needing enteral nutrition support due to its ease of use, which can improve compliance. Studies have demonstrated that RELiZORB is safe, well-tolerated, and effective at improving fatty acid absorption. However, these studies were conducted in patients with cystic fibrosis (CF). Unlike CF, pancreatitis is an acute disease with dynamic physiological changes. Additionally, the goal for patients with EPI due to pancreatitis is to resume full oral nutrition without relying on enteral feeding. Therefore, further studies are needed to evaluate the efficacy and impact of RELiZORB in this population.