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

NCT05466838 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-12-24

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Paul Karanicolas, MD, PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05466838 on ClinicalTrials.gov