Project 445649

Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreatoduodenectomy: A Pilot Randomized Controlled Trial (PERQ-UP Pilot)

445649

Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreatoduodenectomy: A Pilot Randomized Controlled Trial (PERQ-UP Pilot)

$352,570
Project Information
Study Type: Unclear
Research Theme: Clinical
Institution & Funding
Principal Investigator(s): Karanicolas, Paul J
Co-Investigator(s): Ball, Chad G; Eeson, Gareth A; Gallinger, Steven; Jiang, Yidi; Leslie, Kenneth; Martel, Guillaume; Moser, Michael; Nanji, Sulaiman; Serrano, Pablo E; Zogopoulos, George
Institution: Sunnybrook Research Institute (Toronto, Ontario)
CIHR Institute: Nutrition, Metabolism and Diabetes
Program: Project Grant
Peer Review Committee: Randomized Controlled Trials
Competition Year: 2021
Term: 2 yrs 0 mth
Abstract Summary

In up to 80% of patients, surgery of the pancreas (most commonly for pancreatic cancer) leads to pancreatic exocrine insufficiency (PEI), a disease where the pancreas no longer makes sufficient digestive enzymes. Tests to diagnose PEI are difficult to perform and have limited availability, therefore most patients only receive treatment for severe, symptomatic PEI, leaving up to 75% of patients untreated. Treatment of mild to moderate PEI with pancreatic enzyme replacement therapy (PERT) may improve quality of life, reduce weight loss and improve overall survival in patients with PEI as a result of cancer. Given the minimal side effects of PERT and serious problems that may occur in untreated PEI, there is a need for well-conducted studies examining this. Findings from this pilot trial randomizing patients to receive PERT or standard of care (PERT only upon presentation of severe symptoms) at the time of discharge following surgery and continuing for 3-months will be used to establish the feasibility of proceeding with a larger trial in Canada to determine if treating all patients with PERT after surgery can decrease weight loss and improve quality of life. Approximately 1200 patients undergo pancreatic surgery each year in Canada and could potentially benefit from this low-risk intervention.

No special research characteristics identified

This project does not include any of the advanced research characteristics tracked in our database.

Keywords
Feasibility Pancreatic Enzyme Replacement Therapy Pancreatic Exocrine Insufficiency Pancreatic Surgery Quality Of Life Randomized Trial Weight Loss