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PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial — PERQ-UP  

Pancreatic Insufficiency Clinical Trial

Official title:
Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial Description

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). This occurs when there are not enough exocrine cells in the pancreas to release enzymes that help with food digestion. Potential symptoms may include bloating, cramping, large and foul-smelling bowel movements (steatorrhea), and other gastrointestinal symptoms like diarrhea, weight-loss, and malnutrition. PEI can be treated with oral pancreatic enzyme replacement therapy (PERT), for example CREON. Many studies have shown that treatment of PEI with PERT is safe, effective, and may improve quality of life, reduce weight loss, improve abdominal symptoms, and may improve overall survival. 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. Participants will be recruited from Ontario hospitals using a two-step eligibility process (pre- and post-operatively) and randomized 1:1 to receive either standard of care or PERT plus standard of care. Outcome measures will be collected 1 and 3 months postoperatively. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05466838
Study type Interventional
Source Sunnybrook Health Sciences Centre
Contact Paul Karanicolas, MD, PhD
Phone 416-480-4774
Email Paul.karanicolas@sunnybrook.ca
Status Recruiting
Phase N/A
Start date January 6, 2023
Completion date August 31, 2024
View Details
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