Clinical trial NCT05466838: PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
Official title: Pancreatic Enzyme Replacement Therapy to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreatic Insufficiency
Keywords: Pancreaticoduodenectomy
Pancreatic enzyme replacement therapy
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients screened who consent
timeFrame: Baseline
measure: Proportion of patients screened who meet eligibility criteria
timeFrame: Baseline
measure: Adherence to PERT
timeFrame: 3 months
measure: Adherence to PERT dosing guidelines
timeFrame: Day 0 (Discharge)
measure: Adherence to PERT dosing guidelines
timeFrame: 1 month
measure: Adherence to PERT dosing guidelines
timeFrame: 3 months
measure: Completeness of dataset
timeFrame: 3 months
measure: Resource requirement for definitive trial
timeFrame: Study completion (1.5 years)
Secondary outcomes:
measure: Weight loss
timeFrame: 1 month, 3 months
measure: Change in Digestive Symptoms Scale from Baseline
timeFrame: 1 month, 3 months
measure: Change in Quality of Life from Baseline
timeFrame: 1 month, 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Paul Karanicolas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: