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

NCT05466838 | Active Not Recruiting

• 1 other identifier: 3962
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Pancreaticoduodenectomy; Pancreatic enzyme replacement therapy

Outcome Measures

Primary Outcomes (8)

• Proportion of patients screened who consent

  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

  Baseline

• Proportion of patients screened who meet eligibility criteria

  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.

  Baseline

• Adherence to PERT

  Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken.

  3 months

• Adherence to PERT dosing guidelines

  Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline

  Day 0 (Discharge)

• Adherence to PERT dosing guidelines

  Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline

  1 month

• Adherence to PERT dosing guidelines

  Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline

  3 months

• Completeness of dataset

  Assessment of completeness of data, loss to follow-up and missing data and reasons for not being able to collect data

  3 months

• Resource requirement for definitive trial

  Each site will complete a survey at the end of the trial to report the amount of time spent on study activities

  Study completion (1.5 years)

Secondary Outcomes (3)

• Weight loss

  1 month, 3 months

• Change in Digestive Symptoms Scale from Baseline

  1 month, 3 months

• Change in Quality of Life from Baseline

  1 month, 3 months

Study Arms (2)

PERT plus Standard of Care

EXPERIMENTAL

Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation

Drug: PERT at discharge; Other: Standard of Care

Standard of Care

OTHER

Standard of care (no PERT) until presentation of PEI symptoms.

Other: Standard of Care

Interventions

PERT at discharge DRUG

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.

Also known as: PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™)

PERT plus Standard of Care

Standard of Care OTHER

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.

PERT plus Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged \>18 years
• Willing and able to provide informed consent and/or have a substitute decision maker (SDM) provide informed consent on behalf of the participant
• Planned PD for any indication AND, at randomization
• PD performed
• Discharge planned within 21 days of surgery

You may not qualify if:

• Contraindication to PERT including:
• Hypersensitivity to porcine protein, pancreatic enzymes or any excipients
• History of fibrosing colonopathy
• Unable to tolerate oral medication
• Current use of PERT OR, at randomization
• Use of PERT at the time of randomization

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (6)

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Exocrine Pancreatic Insufficiency

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Paul Karanicolas, MD, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 20, 2022
• Study Start: January 6, 2023
• Primary Completion: May 31, 2024
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-11

Locations

CA (6)