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Pancreatic Enzyme Replacement Therapy

PERT for Pancreatic Insufficiency (PERQ-UP Trial)

N/A
Recruiting
Led By Paul Karanicolas, MD, PhD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study completion (1.5 years)
Awards & highlights

Summary

This trial aims to determine if starting PERT (pancreatic enzyme replacement therapy) immediately after surgery can improve outcomes in patients undergoing pancreas surgery.

Who is the study for?
This trial is for adults over 18 who've had pancreas surgery and are set to leave the hospital within 21 days. They must be able to consent or have someone do it for them. It's not for those already on PERT, with a history of fibrosing colonopathy, current PERT users, those unable to take oral meds, or allergic to porcine protein.Check my eligibility
What is being tested?
The study tests if starting pancreatic enzyme replacement therapy (PERT) right after pancreas surgery helps patients better than the usual care without immediate PERT. The goal is to see if this approach can improve quality of life post-surgery.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally PERT could cause gastrointestinal symptoms like stomach pain, nausea, diarrhea; potential allergic reactions due to porcine proteins; and changes in blood sugar levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study completion (1.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and study completion (1.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to PERT
Adherence to PERT dosing guidelines
Completeness of dataset
+3 more
Secondary outcome measures
Change in Digestive Symptoms Scale from Baseline
Change in Quality of Life from Baseline
Weight loss

Side effects data

From 2016 Phase 4 trial • 8 Patients • NCT01833897
38%
sedation
25%
headache
13%
phosphenes
13%
hypomania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine and DCS Treatment

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
Standard of care (no PERT) until presentation of PEI symptoms.
Group II: PERT plus Standard of CareExperimental Treatment2 Interventions
Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
661 Previous Clinical Trials
1,553,951 Total Patients Enrolled
Paul Karanicolas, MD, PhDPrincipal InvestigatorSunnybrook Health Sciences Centre
1 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

PERT (Pancreatic Enzyme Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05466838 — N/A
Pancreatic Insufficiency Research Study Groups: PERT plus Standard of Care, Standard of Care
Pancreatic Insufficiency Clinical Trial 2023: PERT Highlights & Side Effects. Trial Name: NCT05466838 — N/A
PERT (Pancreatic Enzyme Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05466838 — N/A
~5 spots leftby Aug 2024
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