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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Proportion of patients screened who consent — Baseline
  Each centre will keep a screening log of all patients who are scheduled to undergo an elective pancreaticoduodenectomy and perform pre-screening to determine eligibility. The number of eligible patients who are approached for and consent to participate, as well as the number of approached eligible patients who decline to participate (and reasons for declining) will be recorded and the proportions will be calculated
• Proportion of patients screened who meet eligibility criteria — Baseline
  Each centre will keep a screening log of all patients who are scheduled to undergo an elective pancreaticoduodenectomy and perform pre-screening to determine eligibility. The eligibility criteria that are unmet will be recorded, including the additional criteria for randomization. This will be used to calculate proportions.
• Adherence to PERT — 3 months
  Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken.
• Adherence to PERT dosing guidelines — Day 0 (Discharge)
  Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
• Adherence to PERT dosing guidelines — 1 month
  Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
• Adherence to PERT dosing guidelines — 3 months
  Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
• Completeness of dataset — 3 months
  Assessment of completeness of data, loss to follow-up and missing data and reasons for not being able to collect data
• Resource requirement for definitive trial — Study completion (1.5 years)
  Each site will complete a survey at the end of the trial to report the amount of time spent on study activities

Trial sites (6)

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