PERT to Improve Quality of Life in Patients Undergoing Pancreaticoduodenectomy: A Pilot Randomized Controlled Trial (PERQ-UP)

Sunnybrook Health Sciences Centre

Status: Active, not recruiting

Conditions: Pancreatic Insufficiency

Treatments: Drug: PERT at discharge; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05466838

3962 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 2 patient groups

PERT plus Standard of Care

Experimental group

Description:

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

Treatment:

Other: Standard of Care

Drug: PERT at discharge

Standard of Care

Other group

Description:

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

Treatment:

Other: Standard of Care