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Active, Not Recruiting

NCT Number: NCT05466838

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Insufficiency Digestive System Diseases Exocrine Pancreatic Insufficiency Pancreatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences Centre, Hamilton, Ontario, Canada

Loading trial locations.

About this study

After pancreas surgery, patients may develop pancreatic exocrine insufficiency (PEI). This occurs when there are not enough exocrine cells in the pancreas to release enzymes that help with food digestion. Potential symptoms may include bloating, cramping, large and foul-smelling bowel movements (steatorrhea), and other gastrointestinal symptoms like diarrhea, weight-loss, and malnutrition. PEI can be treated with oral pancreatic enzyme replacement therapy (PERT), for example CREON. Many studies have shown that treatment of PEI with PERT is safe, effective, and may improve quality of life, reduce weight loss, improve abdominal symptoms, and may improve overall survival. 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.

Participants will be recruited from Ontario hospitals using a two-step eligibility process (pre- and post-operatively) and randomized 1:1 to receive either standard of care or PERT plus standard of care. Outcome measures will be collected 1 and 3 months postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™)

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.

Primary outcomes

  1. Proportion of patients screened who consent

    Time frame: 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

  2. Proportion of patients screened who meet eligibility criteria

    Time frame: 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.

  3. Adherence to PERT

    Time frame: 3 months

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

  4. Adherence to PERT dosing guidelines

    Time frame: Day 0 (Discharge)

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

  5. Adherence to PERT dosing guidelines

    Time frame: 1 month

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

  6. Adherence to PERT dosing guidelines

    Time frame: 3 months

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

  7. Completeness of dataset

    Time frame: 3 months

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

  8. Resource requirement for definitive trial

    Time frame: 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

Secondary outcomes

  1. Weight loss

    Time frame: 1 month, 3 months

    Difference in weight (kg) from baseline

  2. Change in Digestive Symptoms Scale from Baseline

    Time frame: 1 month, 3 months

    Measured using PAN26 quality of life questionnaire which specific to pancreatic cancer and must be administered in conjunction with QLQ-C30. Scores range from 0 to 100 and consist of functional scales and symptoms scales. A high score on the symptoms scales indicates a high level of symptomatology. A high score on the functional scales indicates a high level of functioning.

  3. Change in Quality of Life from Baseline

    Time frame: 1 month, 3 months

    Measured using the QLQ-C30 quality of life questionnaires. QLQ-C30 is a validated questionnaire that assesses health-related quality of life (QoL) in cancer patients. Scores for both questionnaires range from 0 to 100 and consist of functional scales and symptoms scales. A high score on the symptoms scales indicates a high level of symptomatology. A high score on the functional scales indicates a high level of functioning.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial

Acronym: PERQ-UP

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jul 20, 2022
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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