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

Last updated: December 19, 2024
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pancreatitis

Pancreatic Disorders

Treatment

Standard of Care

PERT at discharge

Clinical Study ID

NCT05466838
3962
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Contraindication to PERT including:

  2. Hypersensitivity to porcine protein, pancreatic enzymes or any excipients

  3. History of fibrosing colonopathy

  4. Unable to tolerate oral medication

  5. Current use of PERT OR, at randomization

  6. Use of PERT at the time of randomization

Study Design

Total Participants: 166
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase:
Study Start date:
January 06, 2023
Estimated Completion Date:
August 31, 2027

Study 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.

Connect with a study center

  • Hamilton Health Sciences Centre

    Hamilton, Ontario
    Canada

    Site Not Available

  • Kingston General Hospital

    Kingston, Ontario
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario
    Canada

    Site Not Available

  • The Ottawa Hospital

    Ottawa, Ontario
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • University Health Network

    Toronto, Ontario
    Canada

    Site Not Available

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