Pancreatic InsufficiencyPERQ-UPNCT05466838
PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
A study testing PERT at discharge in people with Pancreatic Insufficiency, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Insufficiency
- What is being tested?
- PERT at discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 6 sitesCanada
- Study dates
- 6 Jan 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Hamilton Health Sciences Centre
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Sciences Centre
London, Ontario
The Ottawa Hospital
Ottawa, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario
About this study
Official title: Pancreatic Enzyme Replacement Therapy 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.
Read the detailed description
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.
- Conditions
- Pancreatic Insufficiency
- Being tested
- PERT at discharge, Standard of Care
- Keywords
- Pancreaticoduodenectomy, Pancreatic enzyme replacement therapy
- Medical subject headings
- Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PERT at dischargeDrug
Also called PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™)
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.
Standard of CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| PERT plus Standard of Care | Experimental | Initiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation Receives: Drug: PERT at discharge; Other: Standard of Care |
| Standard of Care | Other | Standard of care (no PERT) until presentation of PEI symptoms. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline
Adherence to PERT
Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken.
Measured: 3 months
Adherence to PERT dosing guidelines
Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
Measured: 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
Measured: 1 month
Adherence to PERT dosing guidelines
Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline
Measured: 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
Measured: 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
Measured: Study completion (1.5 years)
Secondary outcomes (3)
Weight loss
Difference in weight (kg) from baseline
Measured: 1 month, 3 months
Change in Digestive Symptoms Scale from Baseline
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.
Measured: 1 month, 3 months
Change in Quality of Life from Baseline
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.
Measured: 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start6 Jan 2023
- Primary completion31 May 2024
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Karanicolas, MD, PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05466838
- Sponsor's protocol ID
- 3962
- Acronym
- PERQ-UP
- Status last verified
- Nov 2024
- First submitted
- 29 Jun 2022
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05466838
- Acronym / sponsor ID
- PERQ-UP / 3962
- Conditions
- Pancreatic Insufficiency
- Keywords
- Pancreaticoduodenectomy, Pancreatic enzyme replacement therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PERT plus Standard of Care | Experimental | Drug: PERT at discharge, Other: Standard of CareInitiation of PERT at time of discharge post pancreaticoduodenectomy with dose escalation upon symptom presentation |
| Standard of Care | Other | Other: Standard of CareStandard of care (no PERT) until presentation of PEI symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindication to PERT including:
- Current use of PERT OR, at randomization
- Use of PERT at the time of randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PERT at dischargeAlso: PrCREON MINIMICROSPHERES®25 or similar (PrCotazym® ECS, PrPANCREASE® MT, PrVIOKACE™)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. | Drug | PERT plus Standard of Care |
| Standard of CareInitiation 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. | Other | PERT plus Standard of Care, Standard of Care |
Primary outcome
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
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.
Adherence to PERT
Time frame: 3 months
Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken.
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
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
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
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
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
3 secondary outcomes
Weight loss
Time frame: 1 month, 3 months
Change in Digestive Symptoms Scale from Baseline
Time frame: 1 month, 3 months
Change in Quality of Life from Baseline
Time frame: 1 month, 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Karanicolas, MD, PhD principal investigator
Sunnybrook Health Sciences Centre
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PERT at discharge in people with Pancreatic Insufficiency, run by Sunnybrook Health Sciences Centre at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients screened who consent (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.