166 Participants Needed

PERT for Pancreatic Insufficiency

(PERQ-UP Trial)

Recruiting at 5 trial locations
MM
PK
PM
Overseen ByProject Manager
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sunnybrook Health Sciences Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

PK

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

Planned PD for any indication AND, at randomization
I am older than 18 years.
Willing and able to provide informed consent and/or have a substitute decision maker (SDM) provide informed consent on behalf of the participant
See 2 more

Exclusion Criteria

I am currently using pancreatic enzyme replacement therapy.
I cannot take medicine by mouth.
I am currently using pancreatic enzyme replacement therapy.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Baseline

Treatment

Participants receive PERT or standard of care post pancreaticoduodenectomy

3 months
Visits at 1 month and 3 months postoperatively

Follow-up

Participants are monitored for safety and effectiveness after treatment

1.5 years

Treatment Details

Interventions

  • PERT
Trial Overview The study tests if starting pancreatic enzyme replacement therapy (PERT) right after pancreas surgery helps patients better than the usual care without immediate PERT. The goal is to see if this approach can improve quality of life post-surgery.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Standard of care (no PERT) until presentation of PEI symptoms.
Group II: PERT plus Standard of CareExperimental Treatment2 Interventions
Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials
693
Recruited
1,569,000+

Findings from Research

Pancreatic enzyme replacement therapy (PERT) significantly improves fat absorption in patients with chronic pancreatitis, with a coefficient of fat absorption increasing from 63.1 to 83.7, indicating its efficacy in treating exocrine pancreatic insufficiency.
PERT also enhances overall nutritional status and quality of life without significant adverse events, suggesting it is a safe and effective treatment, especially when higher doses or enteric-coated formulations are used.
Efficacy of pancreatic enzyme replacement therapy in chronic pancreatitis: systematic review and meta-analysis.de la Iglesia-García, D., Huang, W., Szatmary, P., et al.[2022]
Pancreatic enzyme replacement therapy (PERT) significantly improves fat absorption (CFA) in patients with exocrine pancreatic insufficiency (EPI), with a mean difference of 26.56 compared to baseline and 17.97 compared to placebo, based on a meta-analysis of 7 randomized controlled trials involving 282 patients.
The study found that PERT is effective and well-tolerated, with no significant differences in adverse events compared to placebo, suggesting it is a safe treatment option for EPI.
Efficacy and safety of pancreatic enzyme replacement therapy on exocrine pancreatic insufficiency: a meta-analysis.Gan, C., Chen, YH., Liu, L., et al.[2022]
In a study involving 54 patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis or pancreatic surgery, pancrelipase significantly improved fat absorption (CFA) and nitrogen absorption (CNA) compared to placebo, indicating its efficacy in treating maldigestion.
The safety profile of pancrelipase was comparable to that of placebo, with similar rates of treatment-emergent adverse events, suggesting it is a safe option for patients with EPI.
Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial.Whitcomb, DC., Lehman, GA., Vasileva, G., et al.[2022]

References

Efficacy of pancreatic enzyme replacement therapy in chronic pancreatitis: systematic review and meta-analysis. [2022]
Pancreatic enzyme treatment in chronic pancreatitis: Quality of management and adherence to guidelines-A cross-sectional observational study. [2022]
Pancreatic Enzyme Replacement Therapy in Patients Undergoing First-Line Gemcitabine Plus nab-paclitaxel for Advanced Pancreatic Adenocarcinoma. [2022]
A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer. [2019]
Enzyme replacement improves survival among patients with pancreatic cancer: Results of a population based study. [2023]
Study design considerations for evaluating the efficacy and safety of pancreatic enzyme replacement therapy in patients with cystic fibrosis. [2021]
Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. [2022]
Delayed release pancrelipase for the treatment of pancreatic exocrine insufficiency associated with cystic fibrosis. [2022]
Efficacy and safety of pancreatic enzyme replacement therapy on exocrine pancreatic insufficiency: a meta-analysis. [2022]
Clinical evaluation of an evidence-based method based on food characteristics to adjust pancreatic enzyme supplements dose in cystic fibrosis. [2022]
Prescription patterns of pancreatic enzyme replacement therapy for patients with pancreatic cancer in the United States. [2023]
A 6-month, open-label clinical trial of pancrelipase delayed-release capsules (Creon) in patients with exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery. [2011]
13.United Statespubmed.ncbi.nlm.nih.gov
Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. [2022]
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