Overview

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

Status:
Not yet recruiting

Trial end date:
2024-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sunnybrook Health Sciences Centre

Criteria

Inclusion Criteria:

1. Adults aged >18 years

2. Willing and able to provide informed consent and/or have a substitute decision maker
(SDM) provide informed consent on behalf of the participant

3. Planned PD for any indication AND, at randomization

4. PD performed

5. Discharge planned within 21 days of surgery

Exclusion Criteria:

1. Contraindication to PERT including:

1. Hypersensitivity to porcine protein, pancreatic enzymes or any excipients

2. History of fibrosing colonopathy

3. Unable to tolerate oral medication

2. Current use of PERT OR, at randomization

3. Use of PERT at the time of randomization