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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05466838
Other study ID # 3962
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 6, 2023
Est. completion date August 31, 2024

Study information

Verified date June 2024
Source Sunnybrook Health Sciences Centre
Contact Paul Karanicolas, MD, PhD
Phone 416-480-4774
Email Paul.karanicolas@sunnybrook.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adults aged >18 years 2. Willing and able to provide informed consent and/or have a substitute decision maker (SDM) provide informed consent on behalf of the participant 3. Planned PD for any indication AND, at randomization 4. PD performed 5. Discharge planned within 21 days of surgery Exclusion Criteria: 1. Contraindication to PERT including: 1. Hypersensitivity to porcine protein, pancreatic enzymes or any excipients 2. History of fibrosing colonopathy 3. Unable to tolerate oral medication 2. Current use of PERT OR, at randomization 3. Use of PERT at the time of randomization

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PERT at discharge
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:
Standard of Care
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.

Locations

Country Name City State
Canada Hamilton Health Sciences Centre Hamilton Ontario
Canada Kingston General Hospital Kingston Ontario
Canada London Health Sciences Centre London Ontario
Canada The Ottawa Hospital Ottawa Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Adherence to PERT Recorded on participant's medication tracker and calculated as a percentage of expected vs. actual doses taken. 3 months
Primary 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)
Primary Adherence to PERT dosing guidelines Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline 1 month
Primary Adherence to PERT dosing guidelines Review of medical record for appropriate use of PERT dosing guidelines, comparing actual prescription to dosing guideline 3 months
Primary 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
Primary 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 Weight loss Difference in weight (kg) from baseline 1 month, 3 months
Secondary 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. 1 month, 3 months
Secondary 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. 1 month, 3 months
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