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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

PERQ-UP Trial 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.

PERQ-UP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ study completion (1.5 years)

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%

Study treatment Arm

Ketamine and DCS Treatment

PERQ-UP 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,522 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical centers are offering this trial?

"This trial is currently being conducted at 6 sites, located in Toronto, Kingston and London as well as a few more. To limit the burden of travel for participants it would be prudent to select the closest medical centre to you when enrolling."

Answered by AI

Is enrollment still open for participation in this experiment?

"Clinicaltrials.gov data indicates that this medical research is no longer recruiting participants; however, there are 10 additional studies currently seeking enrolment as of July 18th 2022. This trial was initially posted on August 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05466838.