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PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
Sponsor: Sunnybrook Health Sciences Centre
Summary
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.
Official title: Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
166
Start Date
2023-01-06
Completion Date
2027-08-31
Last Updated
2024-12-24
Healthy Volunteers
No
Conditions
Interventions
PERT at discharge
Starting dose 50,000 units lipase per meal with 3 meals planned per day and 25,000 units of lipase per snack with 2 snacks planned per day. Dose escalation 100,000 units lipase with meals and 50,000 units with snacks.
Standard of Care
Initiation of PERT if clinical symptoms of PEI develop or worsen. Starting dose 50,000 units lipase per meal with 3 meals planned per day and 25,000 units of lipase per snack with 2 snacks planned per day.
Locations (6)
Hamilton Health Sciences Centre
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada