PERT for Pancreatic Insufficiency
(PERQ-UP Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using pancreatic enzyme replacement therapy (PERT).
What data supports the effectiveness of the treatment PERT for pancreatic insufficiency?
Research shows that PERT (pancreatic enzyme replacement therapy) is effective in improving survival and reducing symptoms related to digestion problems in patients with pancreatic cancer and chronic pancreatitis. In a study, patients with pancreatic cancer who received PERT lived significantly longer than those who did not.12345
Is pancreatic enzyme replacement therapy (PERT) generally safe for humans?
Pancreatic enzyme replacement therapy (PERT) has been evaluated for safety in patients with cystic fibrosis and exocrine pancreatic insufficiency. The FDA requires all PERT products to undergo safety studies before approval, and several PERT products have been approved, indicating they are generally considered safe for human use.678910
How is the drug PERT different from other treatments for pancreatic insufficiency?
PERT, specifically in the form of pancrelipase delayed-release capsules like CREON, is unique because it provides a controlled release of enzymes to aid digestion, which is crucial for preventing malnutrition and weight loss in patients with exocrine pancreatic insufficiency due to conditions like chronic pancreatitis or pancreatic surgery.27111213
What is the purpose of this trial?
After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). PEI can be treated with oral pancreatic enzyme replacement therapy (PERT). However, the diagnosis of PEI is difficult and the guidelines about when to start PERT after pancreas surgery are conflicting. This pilot study aims to determine the feasibility of implementing a large-scale clinical trial to definitively evaluate if starting PERT immediately after surgery can improve outcomes in patients undergoing pancreas surgery.
Research Team
Paul Karanicolas, MD, PhD
Principal Investigator
Sunnybrook Health Sciences Centre
Eligibility Criteria
This trial is for adults over 18 who've had pancreas surgery and are set to leave the hospital within 21 days. They must be able to consent or have someone do it for them. It's not for those already on PERT, with a history of fibrosing colonopathy, current PERT users, those unable to take oral meds, or allergic to porcine protein.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PERT or standard of care post pancreaticoduodenectomy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- PERT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor