PERT for Pancreatic Insufficiency
(PERQ-UP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if starting pancreatic enzyme replacement therapy (PERT) immediately after pancreas surgery benefits patients at risk of developing pancreatic exocrine insufficiency (PEI). PEI occurs when the pancreas fails to release enough enzymes for proper digestion. The trial will compare two groups: one receiving PERT soon after surgery and another following usual care, which delays PERT until PEI symptoms appear. Candidates include those scheduled for pancreas surgery who can take oral medication. As an unphased trial, this study allows patients to contribute to important research that could enhance post-surgery care.
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).
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that pancreatic enzyme replacement therapy (PERT) is generally safe and well-tolerated by patients. Studies have found that PERT helps people with exocrine pancreatic insufficiency (EPI), a condition where the pancreas doesn't produce enough digestive enzymes. Patients using PERT report good tolerance, and no major safety issues have emerged in these studies.
One study found that a specific brand of PERT, PANCREAZE®, was safe for treating EPI, particularly in patients with cystic fibrosis. Although this study focused on a specific group, it supports the overall safety of PERT.
The timing for starting PERT can vary, but the treatment is considered safe after pancreas surgery. Therefore, participants considering this trial can feel confident about the safety of PERT.12345Why are researchers excited about this trial?
Researchers are excited about PERT (Pancreatic Enzyme Replacement Therapy) for pancreatic insufficiency because it offers immediate intervention post-surgery, unlike the standard approach that waits for symptoms to appear before starting treatment. This proactive strategy could potentially reduce the severity and duration of symptoms by providing necessary enzymes right after pancreaticoduodenectomy. Additionally, the flexibility of dose escalation based on symptom presentation allows for a more personalized approach, tailoring the treatment to individual patient needs.
What evidence suggests that PERT might be an effective treatment for pancreatic insufficiency?
Research shows that Pancreatic Enzyme Replacement Therapy (PERT) effectively treats pancreatic exocrine insufficiency (PEI). Studies have found that PERT improves digestion and nutrient absorption in people with PEI. A review of research highlighted that PERT can reduce symptoms like diarrhea and weight loss. Another study found that PERT is generally safe and helps maintain body weight and nutrition. In this trial, one group will receive PERT plus standard care, while another group will receive only standard care until PEI symptoms appear. These findings support using PERT to manage PEI, especially after pancreas surgery.678910
Who Is on the Research Team?
Paul Karanicolas, MD, PhD
Principal Investigator
Sunnybrook Health Sciences Centre
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- PERT
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor