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

NAActive, not recruitingINTERVENTIONAL
Enrollment

166

Participants

Timeline

Start Date

January 6, 2023

Primary Completion Date

May 31, 2024

Study Completion Date

August 31, 2027

Conditions
Pancreatic Insufficiency
Interventions
DRUG

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.

OTHER

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.

Trial Locations (6)

Unknown

Hamilton Health Sciences Centre, Hamilton

Kingston General Hospital, Kingston

London Health Sciences Centre, London

The Ottawa Hospital, Ottawa

University Health Network, Toronto

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

All Listed Sponsors
lead

Sunnybrook Health Sciences Centre

OTHER