drugset
drugset / Trial / NCT05466838

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

NCT05466838 ↗

Active not recruiting 166 enrolled Sunnybrook Health Sciences Centre
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-01-06
Primary completion
2024-05-31
Completion
2027-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pancrelipase Protein / enzyme biologic 25000 iu Oral
Subject Pancrelipase Protein / enzyme biologic 50000 iu Oral
Subject Pancrelipase Protein / enzyme biologic 100000 iu Oral
Subject PrCotazym® ECS Unknown 25000 iu Oral
Subject PrCotazym® ECS Unknown 50000 iu Oral
Subject PrCotazym® ECS Unknown 100000 iu Oral
Subject PrPANCREASE® MT Unknown 25000 iu Oral
Subject PrPANCREASE® MT Unknown 50000 iu Oral
Subject PrPANCREASE® MT Unknown 100000 iu Oral
Subject PrVIOKACE™ Unknown 25000 iu Oral
Subject PrVIOKACE™ Unknown 50000 iu Oral
Subject PrVIOKACE™ Unknown 100000 iu Oral

Indications

exocrine pancreatic insufficiency